Regulatory Procedures Manual

Chapter 6: JUDICIAL ACTIONS

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NOTE: For actions resulting from a Current Good Manufacturing Practice (CGMP) or

Quality System (QS) inspection of a domestic or foreign drug, biologics, or medical

device facility, the firm’s profile status information in the Field Accomplishment and

Compliance Tracking System (FACTS) should be appropriately updated at each stage

in the review process. See “Firm Profile Updates in FACTS” in RPM Chapter 4 for more

information.

This chapter contains the following sections:

Section Topic Page

6-1 SEIZURE............................................................................................................... 4

6-1-1 Purpose .......................................................................................................... 4

6-1-2 General Guidelines for Seizures.......................................................................... 4

6-1-3 Types of Seizures................................................................................................... 8

6-1-4 Direct Reference Seizure Authority................................................................... 10

6-1-5 Approval Process for Seizure and Injunction Cases ...................................... 10

6-1-6 Responsibilities for Seizure Actions.................................................................. 16

6-1-7 Update Inspections .............................................................................................. 19

6-1-8 Seizure Accomplishment and Close-Out Documentation.............................. 20

6-1-9 Disposition of Seized Articles............................................................................. 21

6-1-10 Costs of Supervision............................................................................................ 27

6-1-11 Monitoring Seizure Actions................................................................................. 28

6-1-12 Seizures Involving Other Agencies ................................................................... 28

6-1-13 Issuing Press Releases....................................................................................... 28

6-2 INJUNCTIONS .................................................................................................... 29

6-2-1 Purpose ........................................................................................................ 29

6-2-2 General Guidelines for Injunctions .................................................................... 29

6-2-3 Definitions.............................................................................................................. 30

6-2-4 General Considerations ...................................................................................... 31

6-2-5 Adequate Notice Preceding Injunction Actions ............................................... 32

6-2-6 Prerequisites for a TRO or Preliminary Injunction .......................................... 34

6-2-7 Refreshing Evidence - Updating Inspections................................................... 35
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6-2-8 Approval Process for Seizure and Injunction Cases ...................................... 36

6-2-9 Responsibilities for Injunction Actions .............................................................. 36

6-2-10 Cover Letter to DOJ............................................................................................. 38

6-2-11 Complaint for Injunction ...................................................................................... 39

6-2-12 Declarations .......................................................................................................... 39

6-2-13 Consent Decree.................................................................................................... 42

6-2-14 Costs of Supervision............................................................................................ 42

6-2-15 Compliance Follow-Up ........................................................................................ 43

6-2-16 Vacating Injunctions............................................................................................. 46

6-2-17 Issuing Press Releases....................................................................................... 47

6-3 INSPECTION WARRANTS................................................................................. 47

6-3-1 Purpose ........................................................................................................ 47

6-3-2 Inspection Warrants............................................................................................. 47

6-3-3 Responsibilities..................................................................................................... 48

6-4 SEARCH WARRANTS........................................................................................ 53

6-4-1 Purpose ........................................................................................................ 53

6-4-2 Search Warrants................................................................................................... 53

6-4-3 Procedures ............................................................................................................ 53

6-5 PROSECUTION .................................................................................................. 53

6-5-1 Purpose ........................................................................................................ 53

6-5-2 Referral of Criminal Matters to the Office of Criminal Investigations ........... 53

6-5-3 Special Procedures and Considerations for Park Doctrine Prosecutions... 54

6-5-4 Communication Between OCI and Other FDA Components........................ 56

6-5-5 Processing a Summary and Recommendation............................................... 57

6-5-6 Criminal Prosecution after Section 305 Notice................................................ 57

6-5-7 Criminal Prosecution without Section 305 Notice ........................................... 59

6-5-8 Contempt of Court; Violation of Probation........................................................ 59

6-5-9 Development of Felony Violation....................................................................... 60

6-5-10 Referrals for Criminal Investigation ................................................................... 61

6-5-11 Information and Indictments ............................................................................... 62

6-5-12 Grand Jury Investigations and Secrecy............................................................ 63

6-5-13 Preparation of Summary and Recommendation............................................. 63

6-5-14 Submission of Summary and Recommendation Documents........................ 70

6-6 CIVIL PENALTIES – ELECTRONIC PRODUCT RADIATION CONTROL .......... 71
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6-6-1 Purpose ........................................................................................................ 71

6-6-2 Scope ..................................................................................................................... 71

6-6-3 Legal Authority...................................................................................................... 72

6-6-4 Criteria For Recommending Civil Penalties ..................................................... 72

6-6-5 Penalties ................................................................................................................ 76

6-6-6 Director Responsibilities...................................................................................... 77

6-6-7 CDRH Responsibilities ........................................................................................ 79

6-6-8 DE Responsibilities .............................................................................................. 79

6-6-9 OCC Responsibilities........................................................................................... 80

6-6-10 Appeals .................................................................................................................. 80

6-6-11 Consent Decree of Civil Penalty........................................................................ 80

6-6-12 Case Termination................................................................................................. 80

6-6-13 Injunction and Civil Penalties ............................................................................. 80

6-7 EXHIBITS............................................................................................................ 82

Exhibit 6-1................................................................................................................. 84

Exhibit 6-2................................................................................................................. 97

Exhibit 6-3................................................................................................................. 98

Exhibit 6-4............................................................................................................... 100

Exhibit 6-5............................................................................................................... 102

Exhibit 6-6............................................................................................................... 106

Exhibit 6-7............................................................................................................... 108

Exhibit 6-8............................................................................................................... 109

Exhibit 6-9............................................................................................................... 110

Exhibit 6-10............................................................................................................. 111

Exhibit 6-11............................................................................................................. 116

Exhibit 6-12............................................................................................................. 121

Exhibit 6-13............................................................................................................. 122

Exhibit 6-14............................................................................................................. 123

Exhibit 6-15............................................................................................................. 124

Exhibit 6-16............................................................................................................. 125

Exhibit 6-17............................................................................................................. 126

Exhibit 6-18............................................................................................................. 127

Exhibit 6-19............................................................................................................. 172

Exhibit 6-20............................................................................................................. 179
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Exhibit 6-21............................................................................................................. 183

Exhibit 6-22............................................................................................................. 184

Exhibit 6-23............................................................................................................. 192

Exhibit 6-24............................................................................................................. 194

Exhibit 6-25............................................................................................................. 196

Exhibit 6-26............................................................................................................. 202

Exhibit 6-27............................................................................................................. 203

Exhibit 6-28............................................................................................................. 204

Exhibit 6-29............................................................................................................. 205

Exhibit 6-30............................................................................................................. 213

6-1 SEIZURE

6-1-1 Purpose

This section provides procedures and instructions for initiating, reviewing,

approving, effecting, monitoring, and closing out seizure actions filed

under 21 U.S.C. 334.

The United States of America, as plaintiff, proceeds under the

Supplemental Rules for Certain Admiralty and Maritime Claims

(Supplemental Rules) by filing a Complaint for Forfeiture and obtaining a

warrant for arrest, directing the United States Marshal to seize (take

possession or place in constructive custody of the court) the article. The

theory in a Complaint for Forfeiture is that the article seized is the

defendant, and that the government asks the court to condemn the article

and declare forfeiture for violation of the law by the article itself. Any

interested party, owner, or agent may appear to claim the article by filing a

verified claim stating the nature of his/her interest in the article.

Only a proper claimant may litigate on behalf of the seized article. If there

is no proper claimant, the United States is entitled to condemnation and

forfeiture by default.

6-1-2 General Guidelines for Seizures

Before initiating a seizure case, the compliance officer and ORA 

management will name a lead coordinator from the affected ORA program 

or division unit. ORA management will include involved program division 

directors (PDDs). If the PDD is not located where the action is to take 

place, the PDD should inform the appropriate district director (DD) before 

the action occurs. 
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In this chapter, PDD means the appropriate program division-level 

official(s) or designee. The PDD must consider several factors.

A. Prior Warning

See procedures under RPM Chapter 10 - Other Procedures, 10-2

"Prior Notice," and RPM Chapter 4 - Advisory Actions, 4-1 "Warning

Letters" and specific compliance program and policy guides.

B. Voluntary Hold Or Embargo

If there is concern that the product will be distributed before seizure

can be affected, FDA will determine if the dealer will voluntarily hold

the product or if an embargo will be necessary. State embargoes

should be requested only when there is assurance that the seizure

will be approved by the Agency, or when Direct Reference criteria

have been met. See 6-1-4, Direct Reference Seizure Authority.

For counterfeit drugs and the equipment used to make them, the

FDA can first seize and then file a complaint later. See 21 U.S.C.

334(a)(2) and 372(e)(5).

Also, there are provisions in the statute providing for administrative

detention of devices, drugs or tobacco products [21 U.S.C. 334(g)],

and food [21 U.S.C. 334(h)]. The RPM Chapter 5 sections

"Administrative Detention of Food" at 5-3,”Administrative Detention 

of Drugs at 5-5, and "Administrative Detention of Devices" at 5-6

contain the specifics of the administrative detention procedures.

C. Size Of Lot To Be Seized

Where the retail value of the lot in question is less than two

thousand dollars ($2,000) and when the violation does not involve a

hazard to health, refer the facts relating to the violative goods to

state or local officials wherever possible.

In some instances, lots larger than $2,000 may also be disposed of

by state or local action and lots smaller than $2,000 may be seized.

For example, seizure of lots valued at under $2,000 may be

appropriate when: there is a documented hazard to health; when

the violative product will be incorporated into other products, thus

receiving more extensive distribution (e.g., flour containing

pesticides is used as an ingredient in baked goods); or when the

seizure is necessary to establish a legal precedent.

Certain compliance policy guides, such as the Compliance Policy

Guide (CPG) “Sec. 120.500 Health Fraud – Factors in Considering

Regulatory Action,” may also have governing limits or conditions for

seizure action.
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D. Violations Which Appear Easily Corrected

On occasion, seizures may be instituted against articles for

violations that could have been easily corrected by the owner

without litigation, such as violations of the Fair Packaging and 

Labeling Act (FPLA). If seizures of this nature are questioned by

U.S. Attorneys and judges, it may be pointed out that the violator

has refused to correct after prior notice and that, when informal

procedures are followed, the expenses incurred to ensure that the

goods were in fact brought into compliance would be borne by the

government, rather than the violator. In addition, when informal

reconditioning is attempted, the violator may ship the goods without

bringing them into compliance.

21 U.S.C. 334(d) sets forth the procedure to be followed for

attempted reconditioning of articles found in violation. The bond

required of the claimant and the supervisory powers given to FDA

at the claimant's expense is intended to minimize the chances that

the seized goods will be marketed without being brought into

compliance.

E. Violations When Agency Has Other Means Of Control

Seizure may not be the most appropriate means of control when

the Agency has control over products through other means. An

example would be halting a sponsor’s unlawful shipments of

unlicensed biologics due to possible interference with an ongoing

attempt to obtain a license.

F. Voluntary Reconditioning (except for unapproved drugs)

Voluntary destruction of violative lots before seizure should be

encouraged; however, any person destroying a lot should be made

aware of the National Environmental Policy Act (NEPA)

requirements. A copy of the requirements may be obtained from the

ORA Safety Management Officer, listed on the FDA Intranet page

for “Safety Councils & Committees/EHS Network.”

Under no circumstances should FDA witness the voluntary

reconditioning of unfit goods, regardless of the nature of the

violation or the size of the lot. If a lot is reconditioned, do not

recommend seizure unless it is confirmed by examination that the

lot is still in violation. If the goods are unapproved drugs,

reconditioning is not considered.

G. Continuing Violations

When considering a seizure case for which there is evidence (or

the likelihood) of repeated or continuing violations, ORA should

also consider whether the public could be better protected by

alternative or simultaneous injunctive action. Consideration may

also be given to initiating seizure to quickly obtain control of the
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articles and, either attempting to obtain injunctive relief in a consent

decree or amending the complaint for injunctive relief.

H. Section 702(b) Samples

Section 702(b) of the Federal Food, Drug and Cosmetic Act (also 

known as the FD&C Act [21 U.S.C. 372(b)] requires that a part

(portion) of the sample of a food, drug, or cosmetic collected for

analysis must be provided, upon request, to any person named on

the label or the owner thereof, or his attorney or agent. The

regulation at 21 CFR 2.10(c) provides certain exceptions to this

requirement, but duplicate samples must be available, unless

exempted. Failure to provide a part of the sample may jeopardize

the seizure action as well as any future action based on analysis of

that sample.

I. Preservation Of Shipping Records

The Interstate Commerce Commission regulations (49 CFR

1220.6) require common carriers to keep their records only for one

to three years, depending on the type of carrier and record to be

kept.

Contested seizure cases or prosecutions following the seizure are

often delayed and may not go to trial until more than three years

after the shipments were made. In such instances involving

shipments by common carrier, steps should be taken to preserve

the records that will be essential to prove interstate shipment at the

time of trial.

J. Venue, (Place Of Trial) In Actions Arising Under The Federal Food,

Drug, And Cosmetic Act

“Venue" means the place or locality of trial. In all seizure actions

arising under the Act, the case is initially brought in the court where

the goods are located. The court in which the seizure is

accomplished has jurisdiction.

21 U.S.C. 334(a) states an article may be seized and condemned

by any district court of the United States in whose jurisdiction the

article is found.

It is possible under 28 U.S.C. 1404(b) to obtain a transfer of

proceedings in rem from one judicial division to another judicial 

division within the same judicial district without the consent of the

government.

21 U.S.C. 334(a) and (b) describe situations in which venue can be

changed.

21 U.S.C. 334(a) applies to situations in which the number of

proceedings is limited by law, i.e., misbranding. 21 U.S.C. 334(b)

applies when two or more proceedings involving the same claimant
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and the same issues are pending and is concerned primarily with

consolidation of cases for trial.

In all requests for change of venue, any FDA staff who become

aware of this change should promptly advise the Office of Chief

Counsel (OCC) attorney assigned to the case.

6-1-3 Types of Seizures

A. Mass and Open-ended Seizures

The terms “mass” and “open-ended” are used by FDA to distinguish

these seizures from “lot-specific seizures,” in which a specific lot or

batch of a product is seized. These are internal classifications

without independent legal status. They do not appear in the Letter

to the U.S. Attorney or in the pleadings, but simply allow the agency

to track seizure actions by size and/or impact.

A mass seizure is the seizure of all FDA-regulated products at an

establishment/facility. Mass seizures might be conducted when all

of the products are held in the same environment (e.g., a filthy

warehouse) or are produced under the same conditions (e.g., nonconformance with current Good Manufacturing Practice). A seizure

of products in a filthy warehouse is considered a “mass seizure”

even though it does not include products that are not susceptible to

contamination because of their packaging (e.g., canned goods) or

location (e.g., products kept in a freezer or on a floor of the facility

where there was no evidence of rodent or insect infestation).

Special considerations for mass seizures are described below.

An open-ended seizure is the seizure of all units of a specific

product or products, regardless of lot or batch number, when the

violation is expected to be continuous. An open-ended seizure may

be conducted when a specific product is not approved or bears

violative labeling, or when the violation otherwise extends to all lots

or batches of a product, but not to all of the products in the firm. For

example, seizure of all lots or batches of oxygen in a medical gas

facility that produces other types of gas would be an open-ended

seizure rather than a mass seizure. A mass seizure at this facility

would encompass all gasses produced by the firm.

Recommendations for open-ended seizures are processed in the

same fashion as lot-specific seizures.

B. Multiple Seizures

The term “multiple seizures” is used to describe the seizure of the

same product in more than one district court. Multiple seizures may

be initiated to prevent the continued distribution or use of violative

product at more than one location, particularly product that is

dangerous.
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Section 304(a)(1) of the Act imposes restrictions on certain multiple

seizures, if they are based on the same alleged misbranding and

other conditions are not met. Consult this section of the Act, and

Division of Enforcement (DE), if necessary, before pursuing an

enforcement strategy that will involve multiple seizures of

misbranded product.

C. Mass Seizure — Special Considerations

Mass seizures are different from lot-specific seizures because

pertinent events and evidence frequently change from the time the

investigator documents the violative conditions until the seizure is

effected; for example, new lots arrive, FDA-documented lots may

have been distributed, and some corrective action may have been

taken. These factors can complicate the case and interfere with

prompt settlement or other disposition. Thus, prompt action by the

agency and the Department of Justice (DOJ) is necessary to effect

seizures while the evidence is fresh and accurately reflects the

conditions under which the goods are prepared or held.

Therefore, as a general rule, the evidence of violative conditions

supporting mass seizure, usually determined on the last day of the

Establishment Inspection (EI), should not be more than 30 days old

when the case is transmitted to the U.S. Attorney's Office for filing.

The 30-day rule does not apply if the deviation is a failure that

cannot be corrected within 30 days, for example, the failure to

validate a particular procedure or the failure to have had an

approval to market a new drug. Provide an explanation in the

recommendation why this rule is not applicable when necessary.

Because of the effect that a mass seizure can have on a company,

extra care should be taken to ensure that the evidence warrants the

proposed action against all articles to be seized. The compliance

officer assigned to the case should be thoroughly familiar with the

facts. In addition, OCC will prepare a consent decree which may

include provisions for injunctive relief, based on material provided

by ORA (PDDs as appropriate) and Center.

Special considerations regarding evidence needed in 21 U.S.C.

342(a)(4) mass seizures based on filth are as follows:

1. There must be compelling evidence of significant insanitary

conditions (e.g. current live rodent, insect, bird or other vermin

activity in the location where the food is to be seized). Physical

evidence of filth on each lot of food to be seized is not

necessary.

2. The evidence should demonstrate that the infestation has

resulted in widespread adulteration under 21 U.S.C 342(a)(4) or
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that the live infestation is sufficiently dense and can reasonably

be expected to spread to the food to be mass seized.

Examples of mass seizure cases involving 21 U.S.C. 342(a)(4)

conditions are available from DE.

6-1-4 Direct Reference Seizure Authority

Direct Reference is an option used when there is clear agency policy, for

example, actions based on contamination of certain commodities. Centers

have already concurred with stated policy described in documents that

provide for Direct Reference. When the CPG (under specific commodities

guidance), CPGM, or other guidance provides for Direct Reference,

recommendations should be referred directly to DE. Prior to forwarding the

recommendation, ORA (PDDs as appropriate) should determine that the

article is available for seizure, and that all samples and charges meet the

Direct Reference criteria.

6-1-5 Approval Process for Seizure and Injunction Cases

The approval process set forth below applies to both seizure and

injunction cases. This process was established to increase collaboration

and sharing of evidence at the early stages of case development, to

reduce paperwork, to rule-out unsupportable cases, and to shorten

approval times for all cases. This process is not meant to diminish the role

or responsibility of any participant, nor does it diminish the expectation for

quality. ORA is not required to wait until a judicial action is likely to result

before communicating concerns to any participants prior to the preliminary

assessment (PA) call.

A. Preliminary Assessment (PA) Call:

If all participants have been in communication and are in

agreement to move forward with a case, a PA call may be skipped.

In such cases, the party proposing the action will prepare a

document to be e-signed by the participants and will upload the

signed document in MARCS-CMS (CMS) to document concurrence

to move forward without performing the PA call. The party

proposing the action will inform DE of the decision if it is not one of

the involved parties. Given this documentation, the party proposing

the action can proceed with uploading the Case Initiation Memo

(CIM) and supporting evidence in CMS.

1. Timing:

As soon as practicable after the possibility of conducting a

seizure or injunction is first identified, the party proposing the

injunction or seizure should arrange a PA call between ORA 

(PDDs as appropriate) that would be involved in the proposed

seizure or injunction, the relevant Center(s), DE, and OCC, or
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their designees. When appropriate, the call should occur before

the inspection is over. In cases where there is no formal

inspection, such as when evidence is developed by an online

search, the call should occur after the evidence has been

collected.

2. Key Documents:

In advance of the PA call, the party initiating the call should

create a preliminary assessment work activity in CMS. CMS is

available from FDA’s intranet site under ORA Applications. The

party uploads any evidence supporting a seizure or injunction

(e.g., proof of jurisdiction, photographs/ videos, analytical

worksheets, the 483, product label and labeling), and labels

each entry clearly. Call participants should review the

information in CMS information prior to the call when

practicable.

3. Participants:

The call should include the PDD as appropriate, the relevant

Center(s), DE, OCC Enforcement Advisors and other principals

as appropriate. The lead coordinator will select each participant

in CMS. A principal may designate a representative authorized

to act on behalf of the participant; for example, the Center may

designate the appropriate Office of Compliance to represent the

Center. OCC may be represented by the appropriate Senior

Enforcement Advisor.

4. Topics:

Topics may include: the identity of the firm, type of product

involved, problems revealed by the inspection, public health

risk, jurisdiction and interstate commerce, potential violations of

the statute, supporting evidence, relevant compliance policy

documents, prior compliance history, scientific support, and

potential for a corporate-wide action.

A suggested PA call agenda check list would include, but not be

limited to the following:

a. PA call-in phone number and pass code

b. List of ORA attendees (the compliance officer and the

investigators would be expected to participate)

c. List of attendees from the Center(s), DE, OCC Enforcement

Advisors, and other officials if necessary (and their

telephone numbers to include in CIM)

d. Establishment(s) name(s), FEI number/registration number,

city/state, and brief description of the firm’s

operation/processing
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e. Product(s) description (thorough), including type of

packaging and labeling

f. The overall and most significant problem(s)

g. Associated risk(s) and impact

h. Need for expert and/or health hazard evaluation

i. The recommended action

j. Overall charge scheme (e.g., 21 U.S.C. 342 (a)(4) or 355)

k. A summary of the current significant violations observed,

and dates observed

l. A brief overview of the firm’s compliance history, including

recalls and reportable events

m. Relevant compliance policies

n. Sensitive or controversial issues and concerns

o. Appropriate notification of and coordination with tribal, state,

territories, or local authorities

p. Supporting evidence in CMS, identified by the naming

conventions

q. Additional evidence possessed by call participants important

to the decision whether to proceed with the case (e.g.,

HACCP plan, process flow, floor plan, photographs, batch

records, complaint records, SOPs).

5. Decision:

At the time of the call, the call participants should decide

whether to further pursue the seizure or injunction or should

identify additional evidence (e.g., sample results that are

pending or an expert that is needed). If the participants

identified in the PA call decide not to bring a seizure or

injunction, the matter will not be processed unless an ad hoc

committee decides otherwise using the procedures described

below and in Chapter 10 - Other Procedures, Section 10-8, AD

HOC COMMITTEE. The decisions of the participants are not

final and may be changed as the case develops based on new

information, evidence, or views.

6. Record of call:

The party proposing the action, usually the lead coordinator, will

take notes of the views expressed by the participants during the

call and will circulate an e-mail or other informal communication

briefly summarizing those views to the participants. This

summary and any subsequent comments may also be inserted

into the Case Initiation Memorandum (CIM) in the appropriate
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section, if the decision is to proceed with the case. Please note

that these materials may be subject to review in discovery. If

you have any questions about what should or should not be

shared, please contact OCC.

7. Identify Lead Coordinators and Experts:

Following a decision to pursue a seizure or injunction, the PDD,

the Center(s), DE, and OCC should each assign a contact and a 

single lead coordinator, who will retain those roles of throughout

the case wherever possible. The lead coordinator need not have

been a call participant. For OCC, the lead coordinators will be

the Designated Enforcement Advisor. For the Centers, the lead

coordinators may be from the Office of Compliance. The Center

must begin to identify, retain, or assign an expert in all cases

requiring expert support. Following the call, any new evidence

should be uploaded into CMS and a task should be created and

the lead coordinators should alert participants to review the new

information.

When requesting an expert from the program offices or an

outside expert, the center must:

a. clearly establish what the expert will need to be able to

testify about.

b. review the qualifications of the expert to determine if the

expert has the appropriate knowledge and experience based

on the facts in the case.

c. Once the expert has an opportunity to review the evidence,

discuss with the expert his/her opinion of the case and

identify the strengths and weaknesses in the case. if there

are weaknesses identified by the expert, the Center must

clearly delineate them to OCC and advise if the Center

believes the case should proceed.

8. New Evidence:

Following the call, any new evidence or information should be

uploaded into CMS and a task should be created; the lead

coordinators should alert participants to review the new

information. Notify OCC using the address “OC OCC Case.”

mailbox in Outlook.

B. Case Initiation Memorandum (CIM)

As soon as practicable and, at the latest, within 10 working days of

the last day of inspection, date of receipt of sample analysis, or

date of evidence collection, the party proposing the action should

draft a CIM that includes the views of the participants. The party

proposing the action should upload the CIM and supporting
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evidence into CMS and should notify participants. Notify OCC using

the address “OC OCC Case.” mailbox in Outlook. The lead 

coordinator should convert the PA Work Activity to a case in CMS

for concurrent review by the Center, DE and OCC. The Center, DE,

OCC, and other participants will not be expected to write separate

memoranda, but an expert opinion may need to be obtained and if

so, should be added to CMS.

See Exhibit 6-1 for the Format for CIM.

C. Concurrent Review and Use of CMS:

Generally, the lead coordinators should review the CIM and

supporting evidence concurrently. They should use CMS to

transfer, store, and retrieve relevant documents, set up tasks and

log activities.

Each participant must approve the action with regards to the areas

within its responsibilities for the case to move forward in the

absence of the ad hoc proceeding. If a lead coordinator or any

participant believes the case should not move forward, he or she

should advise the others assigned to the case as soon as possible.

If agreement cannot be reached, the participant(s) with the

dissenting view could then write a brief memorandum requesting

review by an ad hoc committee. See RPM Chapter 10 - Other

Procedures section 10-8, AD HOC COMMITTEE. At the time the

request for an ad hoc committee is made, the review clock will be

tolled and remain tolled until the dispute is resolved. The committee

will immediately establish a time schedule for its review of the case.

The time schedule and the decision remarks made by the ad hoc

committee should be made available in CMS.

If the lead coordinators or the ad hoc committee decide to proceed

with a seizure, the Division will prepare the final letter and legal

pleadings and upload them for OCC review. Upon OCC clearance,

the Division will submit the legal pleadings and United States

Attorney letter, along with an evidentiary package, to the US

Attorney’s Office/DOJ for filing with the Courts. If the lead

coordinators or ad hoc committee decide to proceed with an

Injunction, OCC will draft the DOJ referral letter and legal pleadings

and upload them in CMS. OCC will submit the letter, legal

pleadings, and evidentiary package to the Office of Consumer

Protection Litigation (OCPL)/DOJ for further review and

concurrence. The final signed USA Attorney letter and the filed

complaint will be uploaded by the lead coordinator in CMS.

For seizure actions, the Division seizing office is expected to submit

via CMS the final Letter to the U.S. Attorney and Complaint for

Forfeiture in the form required by the local judicial district in order to

assure that there is a clear understanding of the scope and basis
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for the seizure action. For Injunction actions, OCC will draft the

legal pleadings.

Except for the CIM, formal memoranda are not required; however, it

is expected that there are times when additional written documents

or opinions may be needed to move the action forward. The

participants may use their discretion as to the written form used for

such documents, which should be brief and generated within the

established time frames. The need for these documents will be

determined on a case-by-case basis. To the extent possible,

though, the goal is to keep required writing to a minimum.

All written opinions will be available in CMS.

D. Deadlines:

The default timeframe for the two-step process is 10 working days

from the last date of the Establishment Inspection (EI), or sample

analysis, or evidence collection for the lead coordinator to submit a

CIM and 13 working days from the date of the CIM until the time the

case and all material or significant evidence including the expert

opinion is submitted to DOJ. The deadline may be extended on a

case by case basis where circumstances warrant an extension

(e.g., because of laboratory results that require additional time,

especially complex or voluminous evidence, or an unavoidable

logistical delay).

If the deadline is extended, the requestor develops a time extension

plan (TEP) for the case which includes deadlines for specific tasks

and uploads it in CMS. In emergency situations, the deadline would

be shortened as needed. Where possible, the review of routine

cases should be completed in the most expeditious manner

possible; routine cases may require less than the total of 23

working days.

1. CIM Submission:

The lead coordinator should submit a CIM and all available

material and evidence within 10 working days of the last day of

inspection, date of receipt of sample analysis, or date of

evidence collection.

2. CIM review:

The concurrent review and submission of the case and all

material or significant evidence including the expert opinion to

DOJ or the onset of negotiations for a consent decree with a

firm’s counsel should occur within 13 working days after

submission of the CIM.
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6-1-6 Responsibilities for Seizure Actions

A. Division and Program Responsibilities:

Prior to creating a PA work activity in CMS, the compliance officer

will consult with the director of the compliance branch (DCB) and

other ORA management (PDD as appropriate) to obtain support for

the proposed action. The compliance officer will then create the PA

work activity and upload key documents that support the most

significant violations, initiate the PA call and PA Work Activity in

CMS, and upload a document describing summary views

expressed during the PA call.

If the participants agree that a seizure is warranted, the lead 

coordinator is responsible for writing and uploading the CIM into

CMS and notifying the participants. Notify OCC using the address

“OC OCC Case” in Outlook. The contents of the CIM are described

below. See also subsection 6-1-5 and Exhibit 6-1.

Additional responsibilities may include:

1. Significant changes to the fact pattern that take place after the

initial preliminary assessment call should be communicated to

the lead coordinator as soon as possible. The lead coordinator

is responsible for uploading the new information and evidence

as soon as possible. A new task should be created, and

participants should be alerted about the changes.

2. The seizing office must determine whether the lot is available for

seizure and must determine which cases require an inspection 

to refresh evidence (in conjunction with the Center, OCC and 

DE).

The seizure recommendation should not be forwarded to the

U.S. Attorney unless the lot is available. The lead coordinator

must prepare the appropriate number of copies of the complaint

and the letter to the U.S. Attorney on OCC letterhead. The U.S.

Attorney letter will be signed for the Chief Counsel by the

Program Compliance Branch Director with his/her initials next to

the signature. The documents will then be hand delivered, if

practicable, to the U.S. Attorney. All documents should be

available in CMS and the parties should be notified when these

documents have been made available.

3. When it receives notice that a seizure will be executed, the

seizing office is responsible for promptly notifying the

appropriate Centers, DE, OCC and any other offices or other

tribal, state, local and territorial officials that may be involved in

the case, with a copy to the designated OCC contact persons, 

DoJ/OCPL, and FDA’s Office of Media Affairs The seizing office

is also responsible for adding an activity note in CMS and
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updating the date fields. ORA (PDD), Centers and DE will work

together to determine whether a press release should be

drafted, consistent with the procedures outlined in Exhibit 6-10

of this Chapter, Procedures for Issuing Press Releases on

Enforcement Actions (Seizures & Injunctions). If a press release

is issued, it should be uploaded in CMS.

4. The seizing office is responsible for ensuring appropriate followup on seizure actions until the action is adjudicated, and for

promptly notifying ORA offices (PDDs and DDs as appropriate, 

and DE), the appropriate Center, and OCC of the current status

of the case. The seizing office should log its activities using the

activity notes.

5. The seizing office is responsible for uploading “filed legal

documents” and identifying the dates on which the documents

were filed in CMS.

B. Center Responsibilities:

1. Appropriate Centers are responsible for providing and obtaining

technical/scientific review and support of the case, for assuring

that the case meets regulatory policy requirements and for

providing a clear indication of scientific support for each charge

and each article and for making any medical or technical 

changes in the complaint for Forfeiture.

2. The Center is responsible for preparing for and participating in

the PA call, assigning a lead coordinator (who will retain that

role throughout the review process), assigning a

technical/scientific expert and retaining and obtaining the

concurrence of an outside expert when needed, providing views

to ORA for incorporation into a subsequent summary of the PA

call in CMS, and providing input for the CIM to include with

specificity those charges that can be supported, those that

cannot and the rationale within the time frames outlined above.

3. The Center, with input from ORA PDDs as appropriate, and

OCC as appropriate, is responsible for determining whether

outside experts are necessary to support a case and, if so, for

promptly taking steps to secure such support. See RPM

Chapter 10 subsection 10-10 “Expert Support for Cases” for

further information, including information on paying for expert

support.

4. In those situations where an expert memorandum or declaration

is needed in order to move the action forward, such as in GMP,

HACCP, or similar complex cases, a brief memorandum would

be provided by the expert. Experts to be used, whether from the

Center or outside, should prepare a brief statement that they
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have read the EIRs, CIM, and analytical worksheets, and that

based on this review they can support the following conclusions

that are specifically listed. If they cannot support any particular

conclusions, those should also be listed. The document should

state that they are prepared to testify to the above conclusions

(in court and by sworn declaration). The Center lead coordinator

should upload the expert’s CV and bibliography into the CMS

case file. The concurrent review process encourages increased

communication and collaboration and should allow for early

identification of this need for a written opinion/commentary, as

well as other requirements needed to move a case forward.

Note: Referral of the case will not be delayed by the Center if

an expert has not been identified. However, the Center must be

actively pursuing this matter and providing status reports to

OCC. The Center will alert DE and OCC promptly if there is

difficulty in processing an FDA approval to retain an outside

expert. However, OCC may not be able to proceed without the

support of expert opinion.

5. Each Center is responsible for monitoring industry-wide state of

compliance to determine whether an enforcement strategy

should be developed or revised. Consideration should be based

on priorities, prior similar actions, nature and scope of the

industry. This is necessary to avoid multiple seizures which may

have little effect on correcting the problem. In cases involving

widespread problems, single device seizures, or multiple

seizure campaigns, the seizure should fit into the overall

enforcement strategy to correct the problem.

C. ORA Division of Enforcement (DE) Responsibilities:

1. Reviewing, and providing input to the case team as needed

during the concurrent review process.

2. Ensuring uniform application of policy and procedures across

FDA Centers.

3. Reviewing final agency action; remaining involved in further 

actions after seized goods are claimed to provide expertise in 

development of a potential consent decree. NOTE: The Division 

should discuss the consideration of any regulatory action with 

the Center, DE and OCC. 

D. Office of Chief Counsel (OCC):

1. For seizures, OCC will participate in concurrent review and

provide final legal review of legal documents prepared by the 

Division. OCC will provide the legal assistance necessary for

presentation of the action, including direct assistance to the U.S.

Attorney and the ORA compliance staff.
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2. OCC will insert the FDC number in the letter to the U.S.

Attorney, and make any other necessary changes in the

documents.

3. Upon approval, OCC will send the approved documents

(complaint and letter and ancillary documents) to the Division

where the seizure will be made, with a copy to the Center, DE, 

DOJ/OCL, and FDA’s Office of Media Affairs.

E. New Information:

If significant changes to the fact pattern take place after the initial

call, Centers and ORA offices should immediately notify the lead

coordinators and indicate the location of the new information in

CMS. Examples include correspondence from the regulated entity

or its counsel, memoranda of meetings, requests for meetings, or

additional evidence that has come to light since the referral to

headquarters.

F. Independent Judgment:

All reviewing officials (whether in the program, division, center, or

DE) are expected to exercise independent judgment as to whether

an action or a specific charge should be approved or not approved.

6-1-7 Update Inspections

In situations in which there is a question about the continued existence of

a violative condition at a firm or about the availability of violative goods to

be seized, ORA staff may be asked to conduct an update inspection (or a

buy, sample collection, or similar activity) to confirm that the product or

problem affecting products still exists. If the Center, DE, and OCC agree

that the evidence must be updated for an action to be brought, the 

Division will update the inspection assignment in coordination with the 

Center (If necessary) and upload the assignment in CMS. The Division will

create a task to perform an update inspection in CMS and provide

instructions in the task instructions text box.

NOTE: As a general rule, the evidence of violations, when presented to

the U.S. Attorney, should be no older than 60 days. For mass seizures or

seizures based on GMP violations, there should not be more than 30 days

from the last date of the inspection to the time the case is submitted to the

U.S. Attorney’s Office. If the violations are such that ORA or the Center

can provide assurance that the articles to be seized could not be brought

into compliance within these time frames, the request for update may be

waived.

The update (and any resulting report) will focus on documenting the

continued existence of originally identified problems. The update findings

and the lead coordinator's comments should be transmitted concurrently

to DE, the Center, and OCC via CMS.
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6-1-8 Seizure Accomplishment and Close-Out Documentation

After seizure has been approved, it is the seizing office's responsibility to

provide all litigation support, monitoring and follow-up, to encourage

expeditious handling of the seizure, to track the action to its conclusion, and

to report current status to the program, OCC, the U.S. Attorney, the Center,

the PDD, DE, and the DD as appropriate.

A. Contacts with the U.S. Attorney

Seizure actions involving health hazards require prompt action. The

U.S. Attorney's Manual states that forfeiture actions should be

commenced as soon as possible, particularly where continued

distribution of the article may threaten the health of the public.

The compliance officer should encourage the U.S. Attorney to

promptly file the complaint and to forward a copy of the filed 

complaint, with the civil number and the date of filing, to OCC and

to ORA. The lead coordinator should forward a copy of the filed

complaint to DE, the Center, and OCC.

B. Contacts with The U.S. Marshal

After filing the Complaint for Forfeiture, the lead coordinator may

arrange with the U.S. Marshal to effect seizure when, in the

judgment of ORA, such arrangements are needed to ensure that

the seizure is carried out satisfactorily.

ORA may have to use its personnel to expedite seizures in the

following situations:

1. When a question of the proper identity of the lot exists (e.g.,

commingled lots or complicated labeling).

2. When a mass seizure is involved.

3. Lack of cooperation by the dealer, 18 U.S.C. 401 provides as

follows:

"A court of the United States shall have power to punish by

fine or imprisonment, at its discretion, such contempt of its

authority, and none other, as –

* * *

(3) Disobedience or resistance to its lawful writ,

process, order, rule, decree, or command."

Under this statute, interference with a U.S. Marshal in locating

goods may be charged as contempt of court. The facts should

be referred to the U.S. Attorney and OCC.

NOTE: Considerable time can be expended in assisting the

U.S. Marshal's Service in effecting seizure and taking inventory

of the goods. The standard FDA consent decree provides that
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the government shall recover from the claimant court costs and

fees, and storage and other proper expenses. The term "other

proper expenses" found in 21 U.S.C. 334(e) constitutes an

adequate basis for recovery of the costs involved in assisting

the Marshal in effecting and taking inventory of the goods

seized. The actual hourly salary rate of the investigators rather

than the rate for supervision of reconditioning should be

charged.

C. Seizure Action Report

As soon as the articles have been seized, the seizing office will

promptly notify the OCC attorney, the center, the lead coordinator, 

and DE of the amount and value of each lot seized, and the

Marshal's return date. The division should upload a copy of the

email in CMS under the “Final” Tab.

The information necessary to complete this report is obtained by

the investigator accompanying the U.S. Marshal or directly from the

Marshal. Use Form FD-487. See Exhibit 6-2. If the seizure is not

accomplished, the report should so state and explain briefly why

the lot was not available or could not be attached. If the article is

still violative, provide all known details as to where it went and how

to trace or identify it.

The U.S. is required by Supplemental Rule C (4) to give public

notice through advertisement before the article may be forfeited. In

most districts, the Marshal's office contracts for this at the direction

of the U.S. Attorney.

6-1-9 Disposition of Seized Articles

A. Potential Claimant’s Disposition Options Overview

Following seizure of any products there are three avenues available

to a potential claimant. The claimant may:

1. Do nothing, in which case the article will be disposed of by

default;

2. File claim to the article and enter into a Consent Decree,

admitting the violation, agreeing to pay costs, and seeking to

destroy or rehabilitate the article; or,

3. File claim to the article and contest the action by filing an

answer to the complaint.

Regardless of which avenue is chosen, it is the responsibility of the

seizing office to monitor all activity to ensure a proper termination of

the seizure action and to document the activity with supporting 

evidence placed in CMS. The Center, DE, and OCC Attorney

should be promptly advised of all events in the case.
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NOTE: Any decree entered in a seizure case must contain a

provision condemning the article as being in violation of the law.

Without such a provision, there is no authority for the court to order

destruction of the article or to permit its reconditioning.

The avenues available to a potential claimant are addressed more

specifically below.

B. Disposal

If no claimant appears in the case, the government will move for

default, condemnation, and forfeiture or destruction under a Default

Decree (see Exhibit 6-3). The Decree is prepared by OCC. The

Decree may be entered after the return date has expired (see RPM

"Responsibilities in Default and Consent Decrees").

To prevent premature defaults, OCC prefers the use of a 30-day

time frame following seizure as the return date. Local rules may

differ in your area.

When a Default Decree is entered, the U.S. Marshal disposes of

the article. This disposal may take various forms, including the

following:

1. Constructive Destruction - The article is destroyed by using it for

a constructive purpose, such as donating misbranded but

wholesome food to charity.

2. Sale - If the article may be legally sold, the Marshal may sell it to

recover costs. Products in violation of the laws we administer

normally would not be offered for sale after seizure.

3. Conversion - Human food may often be converted to animal

food, rather than destroyed. If conversion is the method of

destruction, ensure that the product is physically treated to

prevent its diversion to human food. Unless a recent precedent

for conversion of a product to animal food is on file, the Center

for Veterinary Medicine must approve of the reconditioning

process.

4. Destruction - The article may be destroyed by burning, burial, or

dumping. Ensure that the method of destruction is appropriate

under NEPA, and that the article cannot be retrieved.

NOTE: Any Default Decree should contain a statement that the

destruction of the article will be in accordance with relevant laws

including NEPA. When questions arise concerning

environmental impact, contact the ORA Safety Management

Officer, listed on the FDA Intranet page for “Safety Councils & 

Committees/EHS Network,” for assessment of the proposed

method of destruction.
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C. Consent Decree of Condemnation

1. Claim - Any potential claimant must first file with the court a

proper, verified claim stating his/her interest in the property.

Only after a proper claim has been filed may there be

negotiations concerning disposition of the seizure. Should more

than one claim be filed, the court may have to rule on who is the

proper claimant (see Exhibit 6-4). Any FDA staff who learn that

a claim has been filed should notify the OCC attorney

immediately and send a copy of the claim by facsimile as soon

as it is obtained.

2. Consent Decree - Should a claimant appear, it may agree to the

entry of a Consent Decree providing for attempted

reconditioning of the article under seizure. See “Compliance

Officer and OCC Attorney Responsibilities in Default and

Consent Decrees" in 6-1-9 item 10 below. In the event that this

method of response is chosen, there are several steps which

the claimant must follow. These are discussed below:

The claimant (BUT ONLY THE CLAIMANT) may consent to the

entry of a decree condemning the article under seizure and

providing for attempted reconditioning or conversion. No

discussion as to the provisions of a Consent Decree is to be

undertaken before a claim is filed and concurrence from OCC

has been obtained. See Exhibit 6-5.

The Consent Decree must provide for the following items:

a. Condemnation of the article as being in violation of the law.

b. A penal bond approximately twice the retail value of the

article under seizure.

c. Provisions for payment of costs for storage and handling by

the U.S. Marshal and for supervision by FDA before release

of the product.

d. A provision that claimant will attempt to bring the article into

compliance under the supervision of, and to the satisfaction

of, FDA. See the RPM "Compliance Officer and OCC

Attorney Responsibilities in Default and Consent Decrees" in

6-1-9 item 10 below.

NOTE: If recurrence of the same violations that resulted in the

seizure is likely, consider including injunctive provisions to the

decree.

D. Bond

Following entry of the decree, the claimant is required to post a

penal bond (see Exhibit 6-6). This bond should be twice the retail

value of the goods. Its purpose is to ensure that the claimant
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complies with the conditions of the decree and performs the

reconditioning in a satisfactory manner. If the bond is set too low, it

might be profitable for the claimant, after securing release of the

product from the marshal, to sell the product without bringing it into

compliance.

E. Bond Forfeiture Procedures

When part of the seized article disappears, or the terms of the

decree are not complied with, the government may move for

forfeiture of the entire bond. If, in the opinion of ORA, a bond action

should be sought, submit a recommendation for such action, along

with the facts, to OCC for preparation of the necessary papers.

If a claimant chooses, claimant may contest the action, in part or in

its entirety. To do this the claimant must:

1. File a proper, verified statement of interest to the article, and

2. File an answer within 20 days after filing the claim denying any

or all of the allegations in the government's complaint.

Should a contest arise, the matter will be handled the same as any

civil trial and will conclude by a decision of the court after

appropriate consideration of the case.

F. Reconditioning Operations

Upon entry of a court order permitting attempted reconditioning of

seized articles, the seizing office will make the necessary

arrangements for supervision with the claimant to ensure

compliance with the decree. Before the reconditioning operation is

begun, the lead coordinator should make sure that the claimant has

in its possession a formal release by the U.S. Marshal.

Reconditioning may be achieved by various means such as:

segregation of codes, cleaning, reworking, relabeling, or physically

modifying for use as animal feed, or fertilizer that brings the article

into compliance with the law.

1. Reprocessing by Reworking or Cleaning. - Unless ORA has a

recent precedent case of a similar nature, proposals for

reprocessing must be referred to the appropriate Center for

consultation.

2. Relabeling - All proposals for relabeling of drugs, devices,

tobacco products, cosmetics, special dietary foods, and fortified

or infant foods, must be sent to the appropriate Center for prior

comment unless guidelines exist. Other foods may be relabeled

when ORA has a clear precedent for the use of the proposed

labeling, but doubts should be resolved by referral to the Center.
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3. Denaturing - If there are outstanding instructions for the

denaturing of the product involved, these should generally be

followed. If no instructions exist, or if in ORA's judgment the

guidelines should not be followed, the proposal should be

referred to the appropriate Center for consideration.

4. When a court order is entered permitting release of seized

articles to a claimant for reconditioning, it should provide for

supervision of the reconditioning operation by the FDA, at the

claimant's expense. As instructed in the Investigations

Operations Manual Section 2.4.8, the investigator supervising

the operation is required to submit a detailed report.

5. When the court's decree permits the seized articles to be moved

to another division for reconditioning operations, the division in

which the operation is to be performed will supervise the

reconditioning operation. In such cases, the seizing office

should determine that the bond has been posted and the

articles released by the U.S. Marshal before permitting the

goods to be shipped. The seizing office will forward to the lead 

coordinator a copy of the decree and other pertinent data,

before the seized article begins its physical move.

NOTE: All dispositions of seized goods other than destruction are

to receive Center concurrence, unless otherwise noted.

G. Post Seizure Samples

When ORA is considering a related criminal case or when

additional analysis is necessary, determination should be made as

to whether adequate reserve samples are available for court use. If

not, steps should be taken to obtain additional samples before the

Default Decree or Consent Decree of Condemnation is entered and

the articles are destroyed.

If, after a seizure, the claimant obtains a court order to take a

sample from the seized lot, the order should provide for a like

sample to be drawn simultaneously by the government. Unless

there is an immediate need for examination of the sample, it should

be held, under seal, by the seizing office.

H. Notice to Claimant and Notice to U.S. Attorney

Upon completion of the reconditioning, prepare a Notice to

Claimant listing the charges to be paid. See Exhibit 6-7. If no

response is received in 30 days, send a second notice. See Exhibit

6-8. Upon receipt of payment (check made payable to the “United

States Treasury”), the seizing office will advise the U.S. Attorney

that the bond may be canceled insofar as FDA is concerned. See

Exhibit 6-9. Copy OCC but do not send a copy of this letter to the

claimant or its attorney.
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I. Compliance Officer and OCC Attorney Responsibilities in Default

and Consent Decrees

1. General Principles: The general rules that follow (which are

subject to exceptions in unusual cases) are intended to reflect

two principles.

a. Every person in the agency, including the compliance officer

in ORA, the Center compliance officer, the DE case 

reviewer, and the attorney in OCC has a legitimate interest

in seeing that a seizure is processed correctly. Therefore,

there should be full consultation (notification is not

consultation) about the handling of a case, and each should

respect the interest and expertise of the others.

b. The maintenance of good working relationships with U.S.

Attorneys' offices is a matter of concern to both ORA and

OCC. U.S. Attorneys' offices should be made aware that

they can call upon the assistance of officers in ORA 

Divisions and Programs and OCC attorneys at headquarters;

both ORA and OCC must affirmatively include the other in

dealings with U.S. Attorneys' offices.

2. Requirements:

a. All default decrees and consent decrees submitted to a U.S.

Attorney's office for filing in court and decrees drafted by a

U.S. Attorney's office and submitted to FDA for comment

shall be cleared through the assigned OCC attorney and the

Center case officer, after full consultation with the

compliance officer and the DE case reviewer.

i. In the case of a default decree, the consultation and

clearance shall at least consist of a telephone

conversation among the attorney, Center case officer,

DE case reviewer, and the compliance officer. They

shall determine what additional consultation, if any, is

needed.

ii. In the case of a consent decree, a copy of the decree

shall be sent to the OCC attorney, DE case reviewer

and Center case officer.

b. Where OCC is asked by the ORA office or by the U.S.

Attorney's office to prepare a decree, the OCC attorney shall

consult fully with the compliance officer, DE case reviewer,

and with the Center, concerning the decree and, after

reaching agreement with the parties involved, shall transmit

the prepared decree directly to the U.S. Attorney's office,

with a copy to the compliance officer and Center.
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c. No negotiation about the potential modes of compliance for

consent decrees shall be conducted with any prospective

claimant until after a proper claim has been filed.

d. Compliance officers shall not negotiate disposition of a filed

case without prior approval of an attorney in OCC. Any such

negotiation shall be conducted by an attorney from OCC with

DoJ.

e. As soon as it appears to the compliance officer that special

local customs or procedures may affect any case (for

example, giving seized articles to charity), the compliance

officer shall advise the OCC attorney of the local peculiarity.

In participating in the disposition of cases involving a default

or consent decree, OCC attorneys shall be sensitive to

relevant local customs, and shall respect such customs

except when they are contrary to law or agency policy.

f. When an attorney believes that a local custom is contrary to

law or agency policy, the attorney shall bring the matter to

the attention of responsible officials in the manner that will

interfere as little as possible with effective working

relationships between OCC, ORA, and the U.S. Attorney's

office.

6-1-10Costs of Supervision

The following rates shall be used in billing a claimant for supervisory

services in connection with reconditioning, relabeling, or disposal of seized

articles under a Consent Decree.

Investigation time - 267% of GS 11/4

Analytical time - 267% of GS 12/4

The above time is figured at an hourly rate.

Per Diem - Specific rates (41 CFR Part 301) paid to employee, in

high cost areas, per diem is higher

Travel - Current Rate per mile (plus tolls)

Miscellaneous expenses - Actual cost

The minimum charge for services shall be not less than the charge for one

hour. Additional charges shall be in multiples of one-hour, disregarding

fractions of less than 1/2 hour, as follows:

1 to 1 hour 29 minutes - 1 hour charge

1 1/2 to 2 hours - 2 hour charge
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6-1-11Monitoring Seizure Actions

The seizing office should monitor the seizure action regularly to ensure the

expeditious progress of the action. Actions taken during the course of the

seizure adjudication should be processed through the ORA compliance

officer to ensure up-to-date monitoring, accurate record keeping in CMS,

and timely reporting. NOTE: The consideration of any regulatory action 

should be discussed among the ORA Program, DE, OCC and the Center.

6-1-12Seizures Involving Other Agencies

When the proposed seizure may involve another agency of the Federal

Government, contact the appropriate Center for administrative clearance

with the pertinent agency. Also see Memoranda of Understanding on the

FDA Collaboration webpage.

A. National Marine Fisheries Service - U.S. Department of Commerce

If the Center advises that the lot was involved in inspection or

certification by National Marine Fisheries Service - U.S. Department

of Commerce, include the following statement in the seizure

recommendation and proposed letter to U.S. Attorney:

"Although packed under inspection (or under Certificate

No.__), the Center for Foods and Applied Nutrition has

discussed this matter with NMFS and that agency has no

objection to seizure." See Memorandum of Understanding

225-75-7001, 225-86-2000, and 225-09-0008.

B. U.S. Department of Agriculture

After clearance as under NMFS, include a similar statement in the

seizure recommendation. See Memorandum of Understanding 225-

80-2000 and 225-12-0007.

C. Federal Trade Commission

See Memorandum of Understanding 225-71-8003.

D. Environmental Protection Agency

See Memorandum of Understanding 225-73-8010.

E. Department of Labor

See Memorandum of Understanding 225-74-6008.

6-1-13Issuing Press Releases

The recommendation to issue a press release is made jointly by the OCC

attorney assigned to the case, the ORA case officers (the compliance

officer and/or DE), and the Center office of compliance. The decision to

issue a press release is made by FDA’s Office of Public Media Affairs in

accordance with the Transparency Initiative. The roles and responsibilities
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of these offices in making these decisions, and in drafting, clearing, and

issuing press releases are described in “Exhibit 6-10 - Procedures for

Issuing Press Releases on Enforcement Actions (Seizures & Injunctions).”

Follow these procedures and the accompanying models for drafting press

releases concerning seizures and injunction actions. Upload the press

release in CMS.

6-2 INJUNCTIONS

6-2-1 Purpose

The purpose of this section is to provide instructions and define

responsibilities for those ORA units involved in the development,

preparation, processing, and follow-up of injunctions.

6-2-2 General Guidelines for Injunctions

Before initiating an injunction case, the compliance officer and ORA 

management will name a lead coordinator from the affected ORA program 

or division unit. ORA management will include involved PDDs as 

appropriate.

PDD means the appropriate program division-level official(s) or designee. 

The PDD must consider several factors.

An injunction is a civil judicial process initiated to stop or prevent violation

of the law, such as to halt the flow of violative products in interstate

commerce, and to correct the conditions that caused the violation to occur.

See 21 U.S.C. 332; Rule 65, Rules of Civil Procedure. If a firm has a

history of violations, and has promised correction in the past, but has not

made the corrections, the injunction is more likely to succeed. However,

the freshness of the evidence is critical.

For an injunction action to be credible in the eyes of the DOJ, the U.S.

Attorney, and the court, the evidence must be current. Timeliness is an

important factor when considering an injunction action, with or without a

Motion for Preliminary Injunction, or a temporary restraining order (TRO).

However, case quality and credibility must not be sacrificed to meet

guideline time frames. The purpose of the guideline time frames is to limit,

as much as can reasonably be expected, the need to update evidence.

Updating entails extra work at all levels of the case development and

review process and, more importantly, delays obtaining an injunction,

which is intended to stop violations that adversely affect the safety or

quality of products in commerce.

Once a complaint for injunction is filed by the United States, a hearing

may be placed on the court calendar at any time with extremely short

notice. It is imperative that the compliance officer maintains close contact
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with the OCC attorney and the Assistant U.S. Attorney to be aware of any

hearings on FDA actions.

When an injunction is granted, FDA has a continuing duty to monitor the

injunction and to advise the court if the defendants fail to obey the terms of

the decree.

Should the decree be violated, the agency must consider a civil or criminal

contempt of court, or other regulatory action, in as timely a manner as

used in initiating the injunction. It is, therefore, mandatory that FDA

personnel responsible for initiating injunctions also adhere to the

implementation procedure in “Compliance Follow-up.”

6-2-3 Definitions

A. Temporary Restraining Order

Temporary restraining orders are court enforced orders entered to

control an emergency situation. A TRO seeks immediate,

temporary relief (for a period of 10 days, which may be extended

for 10 additional days) prior to the hearing for preliminary injunction.

FDA recommends a TRO when the agency believes that the

violation is so serious that it must be controlled immediately. A

request for a TRO also has the effect of expediting review of the

underlying injunction case by the court. An inadequately

documented TRO request may result in the court viewing the entire

injunction action as lacking credibility.

At the court's discretion, the TRO request may be subjected to a

hearing, which may be ex parte (without the defendants’ presence),

by reviewing the documents and questioning government counsel,

the FDA investigator, the compliance officer, or other FDA

personnel.

B. Preliminary Injunction

Whether or not a TRO has been obtained, a Motion for Preliminary

Injunction is subject to a full hearing in which (1) evidence by

affidavit, or (2) testimony of witnesses is presented, depending on

the practice of the court. Once the motion is granted, or the

defendants consent to the entry of a decree, the preliminary

injunction is in effect.

A preliminary injunction may stand indefinitely on the court record

until the case is settled or a permanent injunction has been

entered, after trial or further briefing. A preliminary injunction may

be dismissed, or further proceedings for permanent injunction may

be set by the court, at the request of either party, at any time.
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C. Permanent Injunction

A Decree of Permanent Injunction may be entered at any time after

the complaint is filed, either following a hearing or as a result of a

negotiated settlement. Defendants in an injunction proceeding may

consent to a Decree of Permanent Injunction just as they consent

to a Consent Decree of Condemnation in a seizure action.

Should the defendant not consent to such a decree, a trial is held in

which, to prevail, the government must prove each element of its

case by a preponderance of the evidence. As its name implies, a

Decree of Permanent Injunction remains in effect until it is

dissolved by an order of the court.

6-2-4 General Considerations

A. When an Injunction May Be Considered

An injunction may be considered for any significant out-ofcompliance circumstance, but particularly when a health hazard

has been identified. Proceeding by injunction does not preclude

institution of additional or concurrent action such as recall, publicity,

seizures, embargo by cooperating officials, or criminal prosecution.

In considering an injunction, the agency must evaluate the

seriousness of the offense, the actual or potential impact of the

offense on the public, whether other possible actions could be as

effective or more effective, the need for prompt judicial action, and

whether it will be able to demonstrate the likelihood of the

continuance of the violation in the absence of a court order.

Injunction will be the action of choice when:

1. There is a current and definite health hazard or a gross

consumer deception requiring immediate action to stop the

violative practice and a seizure is impractical; or

2. There are significant amounts of violative products owned by

the same person, a voluntary recall by the firm was refused or is

significantly inadequate to protect the public, and a seizure is

impractical or uneconomical; or

3. There are long-standing (chronic) violative practices that have

not produced a health hazard or consumer fraud, but which

have not been corrected through use of voluntary or other

regulatory approaches.

4. With respect to a and b above, it is helpful, but not mandatory,

to show that there has been a history of prior violations, and that

previous attempts to correct them through alternative warnings

or sanctions have not been effective. A showing of a violative

history should be made whenever possible, but especially in
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those cases where an imminent danger to health cannot be

alleged.

B. Injunctions in Multiple Jurisdictions

When similar violative practices are found at two or more facilities

under the same corporate management, the ORA office where the

corporate office is located should evaluate the compliance histories

of corporate facilities located in other product and geographic 

jurisdictions to determine whether there are patterns of violations or

trends that indicate the presence of systemic problems that should

be addressed on a multi-jurisdictional basis.

The Centers, ORA offices, programs, and divisions, and DE have a

significant role in assessing these situations and in developing and

coordinating a regulatory approach. The initial and continuing roles

of the various offices in multi-jurisdictional injunctions are described

in the procedures titled “Injunctions (Multi-jurisdiction).” See Exhibit

6-11. These procedures were developed to facilitate planning, and

the timely preparation, processing and review of these types of

cases. They must be followed as soon as a potential Multijurisdiction injunction is identified by ORA or the Center. At its

discretion, the recommending ORA office may invoke these

procedures for a single federal district injunction involving multiple

Centers.

6-2-5 Adequate Notice Preceding Injunction Actions

A. Identifying Individuals

FDA strengthens its injunction actions by demonstrating in the

complaint that FDA made and has documented a conscious effort

to get the objectionable products or practices corrected without

court involvement. For example, the defendants were notified of the

violations (by letter, FDA 483, meeting, telephone call) and, despite

having an opportunity to correct the violations, failed to do so. Prior

notice is not a legal requirement, but can demonstrate a

defendant’s resistance to compliance and enhance the agency’s

request for court intervention.

Although there is no legal requirement to name individuals in

complaints for injunction, the agency believes that by doing so,

individuals not named in the complaint will be more inclined to

prevent violations from occurring in the first instance (general

deterrence) and that named individuals will be more inclined to take

immediate and active interest in seeing that the violation ceases

(specific deterrence). Also, the identification of the responsible

persons will prevent their pretense that they were not subject to the

injunction, and will help prevent circumvention of the injunction by

changing the name of the corporation. Therefore, the individuals
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who have the authority and responsibility to correct or prevent the

violations should be named as defendants.

During its normal case-development process, FDA will therefore

strive to identify the individuals with the authority to take corrective

actions and prevent future violations and to develop evidence

proving the individuals’ authority and responsibility. Such

individuals may be located at the sites of the actual or potential

violation, at other offices and sites, or both. When there are

questions concerning individual responsibility during the review

process, assignments should be issued requesting further

documentation. One principal purpose of these efforts is to ensure

that individuals standing in positions of authority with respect to

actual or potential violative conditions will be provided with

adequate notice concerning the evidence found by FDA. The

management officials believed by FDA to have the highest level of

authority in an organization should always receive notice.

B. Methods of Giving Notice

Notice may take a variety of forms including letters and notices

from other government agencies, recalls, issuance of FDA 483s,

post-inspection discussions, meetings, and telephone calls. All

persons receiving notice and the circumstances (date, time, place,

and substance) of notice should be documented. Recognizing that

firms under FDA jurisdiction include those ranging from owneroperator to large conglomerates and that the nature of violations

will vary; what is deemed adequate notice will differ from case to

case. Factors to be considered in determining adequacy include,

but are not limited to, complexity of the organizational structure,

duties and authority of persons believed to be responsible, nature

of the violation, compliance history, and the length of time elapsed

between notice and filing of the case. Also, see RPM Chapter 10 -

Other Procedures, 10-2 “Prior Notice” and 10-3 “Regulatory

Meetings.”

The factors listed below will apply in determining the adequacy of

notice. Agency records should show that sometime during case

development:

1. The individuals with authority to prevent or correct violations

have been given appropriate notice of the general conditions

that are violative.

2. There is sufficient information to conclude that proper action to

correct the violations has not been taken or will not be taken

promptly.

3. Reasonable efforts on the part of the agency were made and

documented to get the objectionable product and practice
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corrected without court involvement. Any attempts by the

proposed defendants to correct the problem should also be

reported.

NOTE: There may be cases where exceptions to the need to show

notice through factors 1 through 3 are justified. Justification for such

exceptions must accompany the case submission.

6-2-6 Prerequisites for a TRO or Preliminary Injunction

Note: Injunctions that include requests for a TRO have the highest priority

ranking of all legal actions. Ensuring that criteria for TROs have been met

and that strategies will be developed to halt the violative conduct usually

requires knowledge of FDA issues and experience. For this reason, it is

recommended that experienced compliance and legal personnel be

involved in all TRO recommendations.

These persons should also be available from each reviewing unit to hand

carry the case to each succeeding level, for review.

A. Timeliness

As a general rule, a request for a TRO should be processed

through the agency so that it may be filed no later than 30 days

after FDA's most recent evidence that the violation is occurring.

Also, as a general rule, a request for a preliminary injunction is

untimely if the evidence to support it is over 60 days old at the time

of filing. The freshness of the evidence is important when the case

includes a Motion for Preliminary Injunction, because the

government is requesting that the matter be moved ahead of other

cases on the court’s calendar because of its urgency.

B. Seriousness of the Violation

In addition to considerations of timeliness, if there is a public health

threat, that factor is something that should be emphasized. It is very

important to remember that we do not need to show potential harm,

but if that factor is present, it is very compelling. If the threat is

severe enough, the court would consider a TRO for immediate

relief.

The magnitude of the violation is another consideration. If the

defendant is a small company with just a few employees and the

violations cause little or no public health risk, a court may not grant

preliminary relief, but may be receptive to granting a permanent

injunction. If the violations are significant and the defendant is a

major presence in the industry, the fact that the violations may have

far-reaching consequences may be a compelling factor in support

of preliminary relief, even if there is no direct evidence of harm.
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C. Adequate Notice

To avoid the need for updating the evidence in requests for TRO or

preliminary injunctions, the agency is committed to prompt review

when all of these prerequisites are met. The absence or weakness

of a prerequisite may preclude review of the request and the

transmission of the case to DOJ until the information is obtained,

unless adequate justification for its omission has been provided.

When initiating requests for injunction with a TRO and in

implementing compliance follow-up, all personnel will perform the

investigational, analytical, and administrative tasks with a high

degree of urgency. Advance notice to all involved units is

necessary, so that plans for expedited processing and review may

be agreed upon and accomplished.

A request for a TRO or preliminary injunction must be accompanied

by an affidavit from the program division directors (PDD and where

appropriate (for example new drug violations), the affidavit of center

personnel attesting to certain facts. Supporting affidavits of experts

should be obtained as soon as possible either by ORA or by the

Center.

Expert witness support is necessary in all cases except when the

violations are so gross and apparent that a reasonable judge who is

not familiar with the technical or scientific issues in the case would

not hesitate to grant the relief without expert testimony. Because

expert testimony takes time to obtain, ORA or the center should

begin identifying suitable candidates and forwarding the necessary

background material to them at the earliest possible time. Please

note that any materials provided to experts must be shared with the

defendants in discovery. If you have any questions about what

should or should not be shared, please contact OCC.

6-2-7 Refreshing Evidence - Updating Inspections

The referral of a Complaint for Injunction to DOJ should follow closely in

time the last evidence of violations (inspectional evidence, laboratory

analysis, or undercover buy), or the last communication from the proposed

defendants which reveals that the violative conduct will continue. This can

be controlled to a certain extent by well-timed reinspection, buys, or

similar activities.

Requests for reinspection, undercover buys, or similar activities should be

coordinated with the Center and OCC. Assignments for update

inspections will be issued directly from the Center after consultation with

OCC. The update findings and ORA's recommendation based upon this

most current evidence should be transmitted concurrently to OCC and the

center.
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6-2-8 Approval Process for Seizure and Injunction Cases

See subsection 6-1-5 for the steps to be included for Injunction cases.

6-2-9 Responsibilities for Injunction Actions

A. Program and Division Responsibilities:

Prior to creating a PA work activity in CMS, the compliance officer

should consult with the DCB and other ORA management to obtain

support for the proposed action. The compliance officer should then

create the PA work activity and upload key documents that support

the most significant violations, initiate the preliminary assessment

call and PA Work Activity in CMS, and upload a document

describing summary views expressed during the PA call.

Note: As described in subsection 6-1-5 above, when the

participants have been working closely on a compliance issue that

will lead to a possible injunction case, the party proposing the

injunction can create an injunction case record in CMS and upload

the CIM and supporting evidence into that record instead of

creating a preliminary assessment work activity.

ORA, along with the Center, is responsible for identifying the

relevant statutes and regulations they seek to charge and with

specificity the relief sought.

If the participants agree that an injunction may be warranted, the

lead coordinator is responsible for writing and uploading the CIM

and supporting documents into CMS. Notify OCC using the address

“OC OCC Case.” mailbox in Outlook. The contents of the CIM are

described in Exhibit 6-1.

When significant changes to the fact pattern that take place after

the initial PA call, these changes should be communicated to the

lead coordinator as soon as possible. The lead coordinator is

responsible for uploading the new evidence as soon as possible. A

new task should be created and participants should be alerted

about the changes.

Upon approval and receipt of final documents from OCC, the 

Division will note the date in CMS that the complaint, transmittal 

letter and ancillary documents were submitted to the district and 

should also make PDF versions available in CMS. The Division will 

upload a PDF version of the signed USA letter and the complaint in 

CMS.
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B. Center Responsibilities:

1. Appropriate Centers are responsible for providing and obtaining

technical and scientific review and support of the case, for

assuring that the case meets regulatory policy requirements and

for providing a clear indication of scientific support for each

charge and each article.

2. The Center is responsible for preparing for and participating in

the PA call, assigning a lead coordinator (who will retain that

role throughout the review process), assigning a

technical/scientific expert and retaining and obtaining the

concurrence of an outside expert when needed, providing views

to ORA for incorporation into a subsequent summary of the PA

call in CMS, and providing input for the CIM to include with

specificity those charges that can be supported, those that

cannot and the rationale within the time frames outlined above.

3. The Center, with input from ORA and OCC as appropriate, is

responsible for determining whether outside experts are

necessary to support a case and, if so, for promptly taking steps

to secure such support. See RPM Chapter 10 section 10-10

“Expert Support for Cases” for further information, including

information on paying for expert support.

4. In those situations where an expert memorandum or declaration

is needed in order to move the action forward, such as in GMP,

HACCP, or similar complex cases, a brief memorandum would

be provided by the expert. Experts to be used, whether from the

Center or outside, should prepare a brief statement that they

have read the EIRs, CIM, and analytical worksheets, and that

based on this review they can support the following conclusions

that are specifically listed. If they cannot support any particular

conclusions, those should also be listed. The document should

state that they are prepared to testify to the above conclusions

(in court and by sworn declaration). The Center lead coordinator

should upload the expert’s CV and bibliography into the CMS

case file. The concurrent review process encourages increased

communication and collaboration and should allow for early

identification of this need for a written opinion/commentary, as

well as other requirements needed to move a case forward.

Note: Referral of the case will not be delayed by the Center if

an expert has not been identified. However, the Center must be

actively pursuing this matter and providing status reports to

OCC. The Center will alert DE and OCC promptly if there is

difficulty in processing an FDA approval to retain an outside

expert. However, OCC may not be able to proceed without the

support of expert opinion.
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5. The Center is responsible for reviewing ORA’s proposal

regarding conduct to be enjoined, ensuring that the proposal is

adequate and reasonable.

6. The Center is responsible for identifying which statutes and

regulations they seek to charge, and with specificity the relief

sought.

7. Each Center is responsible for monitoring industry-wide state of

compliance to determine whether an enforcement strategy

should be developed or revised. This includes a multi-facility

firm that may lead to a Multi-jurisdictional injunction action. See

Exhibit 6-11. Consideration should be based on priorities, prior

similar actions, nature and scope of the industry.

C. ORA Division of Enforcement (DE):

1. Reviewing and providing input to the case team as needed 

during the current review process.

2. Ensuring uniform application of policy and procedures across

FDA Centers.

3. Reviewing final agency action, remaining involved in further 

actions and monitoring after an injunction is entered and

determining which cases require an update inspection (in

conjunction with the Division, OCC and the Center).

D. Office of Chief Counsel Responsibilities:

For injunctions, OCC will participate in concurrent review and

provide legal review, prepare pleadings and other legal documents,

and provide legal assistance necessary for presentation of the

action, including direct assistance to the Office of Consumer

Litigation and/or the U.S. Attorney’s Office and the compliance

staff.

Upon approval of an action, OCC will transmit the final complaint, 

transmittal letter and ancillary documents electronically to the ORA 

Division where action will be taken, with a copy to the designated 

Center and DE contact persons, DOJ/OCL, and FDA’s Office of 

Media Affairs.

6-2-10Cover Letter to DOJ

The cover letter transmitting the case to DOJ/Office of Consumer

Litigation, Civil Division, will be prepared by OCC and will identify the

action sought (TRO, preliminary injunction or permanent injunction), briefly

summarize the case, highlighting legal, evidentiary, and tactical issues

worthy of note including the significance of the evidence.
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6-2-11Complaint for Injunction

OCC will prepare the Complaint for Injunction, in accordance with the

requirements of the Federal Rules of Civil Procedure and any particular

requirements of the relevant district court.

The complaint will generally include sections covering jurisdiction, venue,

identification of defendants, a statement explaining the nature of the

products involved, the purpose of the law that is being violated, a

summary of evidence of the violations alleged, a brief reference to prior

inspections, prior warnings, and historical non-compliance, and a shortform prayer for relief. See Exhibit 6-19.

6-2-12Declarations

Most jurisdictions will accept declarations in support of a motion for

preliminary relief or for a TRO. If the court requires live testimony in

support of a motion for TRO or preliminary injunction, the declaration may

be converted to testimony. Please note that declarations are testimony

given under oath. Declarants should be prepared to testify in court to all

statements made in a declaration.

NOTE: 28 U.S.C. 1746 provides for the optional use of declarations in lieu

of affidavits, thereby avoiding the need for a notary public. This is

particularly useful for experts and resident investigators when a notary is

unavailable. Declarations filed under 28 U.S.C. 1746 have exactly the

same legal weight and significance as affidavits. Where either an affidavit

or declaration is used, follow Exhibit 6-20. The 28 U.S.C. 1746 declaration

should state, "Pursuant to 28 U.S.C. 1746, I declare under penalty of

perjury that the foregoing is true and correct. Executed on (date).”

If the court requires affidavits from investigators or analysts or others

having firsthand knowledge of the facts, they should be furnished by the

ORA office or persons performing the work. However, where significant

information is discovered in the course of the inspection and is not

contained in the FDA 483 or other document, but is within the personal

knowledge of the investigator, that observation, discussion of event, or

incident should be the subject of a brief declaration by the investigator.

Where a separate declaration is used for an investigator, the relevant FDA

483 issued by that investigator should be attached thereto. In some cases,

a declaration may also be necessary for the investigator to summarize and

explain the significance of the most recent inspectional findings consistent

with his or her experience as an FDA investigator.

The only declarations that will routinely be used in support of injunctions

are the declarations of:

A. the PDD, or their designee;
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B. an investigator (where necessary to support information in the

complaint not contained in the FDA 483 or to summarize the

significance of the findings);

C. appropriate Center official (to document such things as the lack of

an NDA or the failure to register a product or facility); and

D. experts.

The declarations should be factual and, except in the case of declarations

by experts, not contain conclusions, or opinions. In all cases, each

declaration must provide clear, succinct, and strong factual support for the

complaint.

The declarations should set forth the identity of the declarant; his/her

position with FDA and his/her duties in that position. If it is an expert's

declaration, his/her qualifications to draw conclusions or offer opinions

must be summarized at the beginning of the declaration and should be

supported with an attached copy of the expert's curriculum vitae.

Because the granting or denial of a TRO or preliminary injunction may rest

upon the sufficiency of the declarations submitted with the complaint, care

should be taken to ensure that every statement in the complaint is covered

with equal or greater specificity in the declaration. Violative conditions

unrelated to the charge should not be included. Unimpressive violative

conditions should not be included; however, a number of less impressive

violative conditions may often be grouped to become more impressive

when their combined effect is to make a potentially hazardous condition.

NOTE: Listing a series of minor infractions has the effect on a court of

minimizing the significance of the case and distracting the focus away

from the significant problems.

The facts in the PDD's declaration are derived from a review of documents

contained in the ORA files and the declaration should so state. A PDD or

investigator may not rely on oral statements made to him or her by other

agency personnel.

A. The following specific information should be covered in the

declaration:

1. statement of the position occupied by declarant;

2. duties of the declarant in that position;

3. legal status or business of the defendant firms;

4. address of business;

5. identity of individual defendants, where they perform their

duties, and in at least as much detail as in the complaint, their

authority and responsibilities;
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6. a statement that the defendants are doing (or do) interstate

business in a product known as (brand name);

7. the label and labeling of the products (If the labeling is available,

it should be attached to the declaration, appropriately identified.

If exhibits are not available, relevant portions of the labeling

should be quoted when applicable to the charges in the

complaint);

8. if relevant to the charges, establishment inspections performed

and the facts revealed thereby;

9. a statement that samples from recent interstate shipments have

been obtained, briefly citing the labeling accompanying the

shipments, if pertinent;

10.sample evidence (include the name of product sampled, and the

laboratory findings that confirm the alleged violations);

11.prior actions such as warnings, notice, seizures, and FDA

attempts to obtain correction, broken promises or other

evidence of bad faith, such as statements by defendants clearly

showing an intent to continue the violations, in detail as pertains

to each defendant; and,

12.a statement that, despite the previous actions, the defendants

are still engaged in violative conduct.

NOTE: All declarations should be prepared in final form, but not be

signed, and should be double-spaced. They represent the facts that

can be sworn to by an individual. However, changes made in a

case during the review process may require changes in the

declarations.

B. To ensure that the declarations remain accurate, the following will

apply:

1. The declarant will carefully review the final copy before the case

is submitted.

The only signed version should be the final version after all

changes have been agreed upon, reviewed, and cleared by the

signer.

2. If substantive changes are made in the declaration, the

reviewing office proposing the change will check with the PDD

to ensure the individual can attest to the truthfulness and

accuracy of the added material. OCC will be responsible for

incorporating all approved changes into the final.

3. In no case will a declaration be modified without the knowledge

and express consent of the declarant.
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6-2-13Consent Decree

OCC will prepare the proposed consent decree, using the section in the

CIM titled “Violations,” and additional information provided by the Center.

ORA and the Center are jointly responsible for providing OCC with the

information necessary to support the specific substantive relief sought.

See Exhibit 6-18.

In drafting a consent decree, OCC will seek Center approval on matters

germane to its original review, including reconditioning or reprocessing

plans, CGMP requirements, reviews of the corrective actions of

defendants, recalls, cessation of product manufacturing or distribution

operations, and measures that could affect availability of medically

necessary products. OCC will seek the approval from ORA (the PDD as 

appropriate) on matters requiring ORA follow-up activities, such as

reinspection frequency and rates, reviews of defendant’s corrective

actions if any were requested by Center, and witnessing destruction and

disposition of goods.

Also, during litigation, representatives of those offices with a direct interest

in the case will keep each other informed of developments, including

changes proposed by DOJ attorneys, to ensure that a consent decree is

filed that are acceptable to the agency (PDD, Center, and OCC).

FDA should not seek relief if it cannot be obtained (e.g., do not propose to

allow reconditioning of a product if it cannot be accomplished). Also, if the

relief provides for the company to obtain a consultant, do not require, as

part of the relief that FDA approve of the consultant.

6-2-14Costs of Supervision

All injunction actions resulting in consent decrees should provide for the

payment of costs incurred in conducting all inspections pursuant to the 

decree. Court orders may also provide for the payment of costs incurred in 

conducting inspections pursuant to the order.

The following charges apply to all injunctions:

Investigation time: 267% of GS-11/4 hourly rate

Analytical time: 267% of GS-12/4 hourly rate

Per diem actually paid to an FDA employee will be paid at the

current existing rates expressed in GSA's Federal Travel Directory.

Miscellaneous expenses: actual cost
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The minimum charge for services shall be not less than the charge for one

hour. Additional charges shall be in multiples of one-hour, disregarding

fractions of less than 1/2 hour, as follows:

1 hour through 1 hour, 29 minutes - charge 1 hour

1-1/2 hours through 2 hours, 29 minutes - charge 2 hours

Consult with OCC before notifying the firm by letter that it may resume

operation (see Exhibit 6-12) and before sending any bill setting forth

charges for any inspection conducted pursuant to the decree or order (see

Exhibit 6-22). Do not use a letter to notify either the firm or the U.S.

Attorney that costs have been paid, because such letter may be 

misconstrued in a way that could have adverse consequences.

Ensure documentation justifying the charges is maintained as part of the 

legal file and discussed with OCC.

6-2-15Compliance Follow-Up

Once the injunction has been granted, the Court and the public rely on

FDA to conscientiously monitor the defendants' compliance and to advise

the Court on compliance with the terms of the injunction.

It is the responsibility of ORA (the PDD as appropriate) to ensure that

prompt attention is given to the following:

A. Consult with OCC as to service of copies of the court's decree.

B. Determine the firm's plans to bring the operation into compliance

and, where applicable, the plans for destruction, reconditioning, or

recall of material on hand and finished goods in the market place.

C. Where the injunction contains a provision for the firm to designate

an expert to supervise compliance with the terms of the decree, it

should specify that the expert must certify in writing to FDA that the

terms of the decree have been complied with before FDA makes

any inspection, and that the firm must submit a written list of

corrections to FDA.

D. Find out whether the firm has hired a qualified expert, and

determine his/her qualifications. FDA does not approve or

disapprove of experts selected by defendants when defendants are

required by a consent decree to retain expert consultants.

However, FDA may elect not to accept a consultant’s report of

findings. FDA acceptance of the consultant's findings may include

consideration of such factors as the adequacy, completeness, or

accuracy of the filed report, if an obvious conflict of interest is

uncovered, or if the consultant’s competency does not meet a

regulatory standard, for example, as required in the drug CGMP

regulations at 21 CFR 211.22. ORA should share the follow up

findings with the Center either by email or telephone.
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E. Monitor status of the accomplishment of the above. Promptly

advise OCC and the appropriate Center of any problems regarding

non-compliance with the decree. Maintain close contact, including

visits, as necessary, to ensure that the firm is brought into

compliance before operations subject to the injunction are

resumed.

NOTE: Inspections made under an injunction are performed under

the authority of the appropriate Act and the decree entered by the

court. When visiting the firm, provide a copy of the decree and FDA

482 to managerial personnel and document that you have done so.

This will facilitate any contempt action that may be necessary.

Following determination by ORA that the defendants appear to be

in compliance with the requirements of the "unless and until"

provisions of the decree, the defendants should be so notified in

writing and advised that such determination does not, however,

relieve them of their responsibility for compliance with the Act or

other provisions of the decree that continue in effect. See Exhibit 6-

12 Model Letter Acknowledging Compliance. Consult with OCC

before notifying the firm by letter (Exhibit 6-12) that it may resume

operations and before sending an initial bill setting forth the charges

for all work performed to get the firm in compliance (Exhibit 6-21).

NOTE: If a copy of the above letter is furnished to the U.S.

Attorney, it may inadvertently trigger a dismissal action unless the

U.S. Attorney is also reminded that there are other provisions of the

injunction that remain in effect.

If ORA's follow-up discloses that the firm has met the provisions of 

the decree and notice has issued, the lead coordinator will 

schedule a follow-up inspection to be performed in 3 to 4 months 

and quarterly thereafter until the firm maintains a continuous state 

of compliance for one year. The firm shall be inspected at least 

annually thereafter. Discretion is permitted to provide flexibility with 

timing of inspections to coincide with different seasons (dry, rainy, 

etc.), as appropriate, to inspect under varying operating conditions. 

Deviation from this schedule is appropriate in those instances 

where plant operations are on a seasonal. In that event, the firm 

shall be scheduled and inspected at the beginning of the next 

operating season.

Should any reinspection or analysis of samples disclose that the

defendants are not meeting the terms of the decree, a variety of

regulatory actions are available to FDA, including:

1. Reinstatement of Decree

Motion to petition the Court to implement the shutdown

provisions of the decree, based on the fact that defendants
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regressed from an in-compliance state (as certified in formal

notice) to an out-of-compliance state. The effect of this action is

to again close the firm until corrections have been made and

verified. If the decree allows for a recall, upon request by FDA,

this, too, may be considered.

2. Seizure

3. Civil Contempt

A civil contempt is a forward-looking action to force compliance,

requesting the court to impose a penalty upon the defendant for

continued noncompliance. The penalty may be monetary or

confinement of individual defendants for each day or for each

violative act until the terms of the decree are met.

4. Criminal Contempt

A criminal contempt action is not to coerce compliance, but to

punish prior behavior. The penalty does not depend upon future

actions.

5. Prosecution

6. Civil money penalties (for example, for medical devices or

tobacco products)

7. Administrative sanctions such as Withdrawal of Applications.

NOTE: The foregoing regulatory actions may be applied

individually, sequentially, or concurrently. The consideration of any

regulatory action should be discussed with the Center, DE, and

OCC.

Recommendations for any action taken as the result of a violation

of a decree shall be processed with the same urgency as the

original injunction, and in accordance with the procedures in this

chapter. The compliance office will prepare a recommendation. For

criminal contempt, see the RPM subsection 6-5-8 "Contempt of

Court; Violation of Probation". For prosecution see subsection 6-5-6

"Criminal Prosecution After 305 Notice." Should contempt be the

action of choice, the lead coordinator will also prepare a Petition for

Order to Show Cause why the defendants should not be held in

contempt. See Exhibits 6-22 and 6-23.

Change in ownership or identity of defendant firm should be noted.

In the case of a change in ownership or corporate identity of the

firm, report detailed facts on the changes to the Center and the

OCC for a determination whether the new ownership or corporate

entity are covered by the injunction. Rule 65(e), Federal Rules of

Civil Procedure, discusses persons covered by injunctions.
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F. If a firm under injunction goes out of business, take the following

steps:

1. Maintain the file as an open injunction for one year.

2. Check the status of the firm at the end of six months and one

year after being reported out of business.

3. Make an effort to determine whether the firm has moved to

another location and another ORA office should be notified of

the status of the firm. Notify any such office about the injunction.

4. If the injunction is against an individual as well as a firm,

determine the individual's present occupation, and whether or

not it is similar to the type of business for which he/she was

enjoined. If so, notify the Center and OCC.

5. If the firm remains out of business after one year, notify OCC

and the appropriate Center of your intention to close the file in

60 days unless either component has further information which

requires consideration.

6. After the 60-day waiting period, if no further information is

received, and the injunction was a preliminary one, notify the

U.S. Attorney in writing that the firm has ceased operations and

the government recommends closing the injunction file.

6-2-16Vacating Injunctions

FDA does not ordinarily initiate requests to vacate injunctions whether

issued by consent decrees or court orders. Nor will the agency join with a

defendant in filing a motion to request such relief. However, if all of the

following apply, FDA may agree to not oppose such a motion:

(1) the agency has recent evidence (e.g., within the last 6-8 months) that

the defendant is in compliance with the Act, applicable regulations, and

the decree or order; (2) the defendant has remained in continuous

compliance with the Act, applicable regulations, and the decree or order

for the life of the sunset provision (virtually always five years); and (3) the

defendant has given FDA an opportunity to consider whether or not to

object to the motion. A long violative history or lack of cooperation by the

defendant will also affect FDA’s response to a motion seeking to have an

injunction vacated.

If a defendant contacts the appropriate ORA office(s) to discuss the

possibility of vacating an injunction, the defendant should be instructed to

prepare a written request specifically describing the evidence to show how

it has met each of the foregoing criteria. ORA and the Center should not

discuss their views about vacating a decree with the defendants or their

counsel. That request should be forwarded to OCC (Deputy Chief Counsel

and Associate Deputy Chief Counsel for Litigation), the relevant Center(s),

and DE, together with the PDD's views, which should include a description
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of the results of the most recent inspection and the defendant's overall

inspection history since the injunction was entered. If OCC, the

program/division, the center, and DE do not object to vacating the

injunction, OCC will inform the defendant's counsel that FDA will not

oppose a motion requesting such relief.

Thereafter, the defendant's counsel should prepare, in draft, a short

motion briefly describing the sunset provision, the defendant's compliance

therewith, and the fact that FDA has read the motion and does not object

to the relief sought. If OCC agrees with the motion, it will take steps to

contact DOJ so that the motion may be filed without opposition from the

United States.

6-2-17Issuing Press Releases

The recommendation to issue a press release is made jointly by the OCC

attorney assigned to the case, the ORA case officers (the compliance

officer or DE), and the Center’s compliance office. The decision to issue a

press release is made by FDA’s Office of Media Affairs in accordance with

the Transparency Initiative. The roles and responsibilities of these offices

in making these decisions, and in drafting, clearing, and issuing press

releases are described in subsection 6-1-13 “Issuing Press Releases.”

See Exhibit 6-10. Follow these procedures and the accompanying models

for drafting press releases concerning seizures and injunction actions.

Upload the press release in CMS.

6-3 INSPECTION WARRANTS

6-3-1 Purpose

To provide procedures for obtaining inspection warrants. Procedures for

Search Warrants are discussed in Section 6-4.

6-3-2 Inspection Warrants

FDA does not routinely request inspection warrants in order to conduct

investigations or inspections of regulated industry. However, warrants

have been used effectively to gather information that has been refused

improperly. Inspection warrants should be recommended as soon as

possible after a refusal is encountered. A past refusal is not a prerequisite

to seeking an inspection warrant. (NOTE: "Inspection warrant" and

"administrative inspection warrant" have the same meaning.)

Inspection warrants may be sought when inspection has been refused

completely or when refusals have been encountered in limited areas; for

example, when photography or sample collection has been refused.

There are situations where FDA will seek a preemptive inspection warrant;

for example, when there is a history of prior refusals from a firm and FDA
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anticipates a current refusal to inspect. Also, FDA may seek a preemptive

inspection warrant prior to initiating a scheduled inspection when there is a

documented corporate policy mandating refusal in a particular area (such

as photography, sample collection, or copying of records), or there is good

reason to believe that required information will be refused and that

information will then be destroyed before an inspection warrant can be

obtained.

Before seeking an inspection warrant, the agency needs to ensure that:

A. FDA is entitled by statute or regulation to inspect the facility and to

have access to the information which has been refused; and

B. there is a compelling FDA need for that information, and

C. the firm/individuals have refused to allow inspection or access to

information in spite of a clear demonstration or explanation of

appropriate statutory authority.

6-3-3 Responsibilities

Recommendations for inspection warrants are given high priority and

handled expeditiously by all offices involved in their review. Under ordinary

circumstances, OCC is not involved with the procedures for determining

the need for an inspection warrant until the responsible center and DE

determine that the application should proceed.

A. Division/District

1. Preliminary Steps

When the criteria for requesting an inspection warrant are not

clear, the lead coordinator should consult with DE prior to

submitting a request for an inspection warrant. DE is located at

10903 New Hampshire Avenue, Silver Spring, MD, 20993

ororaospopenforcementdivio@fda.hhs.gov.

When the PDD decides to recommend an inspection warrant,

the lead coordinator should contact DE by telephone, provide

advance notice, ascertain the DE contact person, obtain any

additional guidance, and upload the documents listed below into

CMS (Compliance Management System).

The Lead Coordinator should transfer the case to DE by 

changing the current owner to DE pursuant to CMS procedures. 

CMS will automatically send an e-mail to the person in DE 

designated to receive notification when actions have been 

submitted to that office. Prior to changing ownership for 

submission of the action, the Lead Coordinator should identify 

all potential or suspect adulteration and/or misbranding charges 

cited in the subject action under the Act/CFR tab in CMS.
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2. What to Include

a. Cover Memorandum. The cover memorandum should

summarize the circumstance(s) justifying the need for an

inspection warrant. The memo must cover the following

elements:

i. The statutory or regulatory authority to conduct the

inspection or to obtain the information.

ii. Why there is a compelling need to conduct the inspection

or obtain the information.

iii. A clear description of the refusals encountered or, if

refusals are anticipated, the reasons why a refusal is

expected. Include a description of the efforts to explain

our statutory authority and the firm’s continued refusal in

spite of this explanation.

iv. Each type of information sought and refused, and an

explanation why the information cannot be obtained

through other means.

v. The status of the inspection (ongoing, terminated, or

anticipated)

vi. The reason for the inspection; prior warrants obtained;

and, if applicable, violations observed.

vii. Any situation that may result in a refusal or delay of an

inspection conducted under a warrant.

viii.Any other pertinent information, for example, that the

location is a personal residence or ORA anticipates

resistance during execution of the inspection warrant, in

which case a strategy for dealing with the anticipated

resistance should be outlined.

ix. Factors that are known to involve danger to the public,

the inspecting persons, or others, for example, weapons,

guard dogs, or hazardous chemicals.

b. Draft Application for Inspection Warrant. The application for

inspection warrant forms the basis for the agency's request

to the Court. If there are multiple locations under the control

of the same firm, prepare individual applications and

warrants to cover each location. The application must

include the following elements:

i. The correct address of the premises to be inspected. If

the inspection is to extend to a vehicle, a precise

description of the vehicle, including the color, make,

model, and license number of the vehicle.

ii. The statutory authority to inspect the establishment and

the items sought.
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iii. Any violations observed during the course of the current

investigation or the most recent inspection, specifically

citing the language and section of the Act being violated.

Although it is not required that a violation has occurred in

order to obtain approval of an inspection warrant, DOJ 

has asked that such information be included in the

Application, when available.

iv. A detailed description of any relevant refusals, including,

for example, and not limited to: the individuals making the

refusals, their titles, the dates of the refusals, any

additional responsible individuals involved in or consulted

about the refusals, the reasons given, any written

corporate policy regarding the refusal, the names of

investigators to whom the refusals were addressed.

v. A detailed description of the reason for our inspection, or

investigation during which the refusal was made,

emphasizing that inspection was made at a reasonable

time, in a reasonable manner, and describing any agency

directives or programs which authorized the inspection

and its scheduling.

vi. A description of the items that will be sought during the

execution of the warrant.

vii. A description of the manner in which the requested

inspection will be conducted pursuant to the warrant,

such as the use of one or more investigators or U.S.

Marshals to accompany the requesting investigator on

the inspection, sample collection, and photography, and,

where appropriate, copying of records.

c. A Draft Warrant. Include a draft copy of the inspection

warrant.

d. Other Information and Documentation. Include any pertinent

supporting documentation or background information.

NOTE: Recent models of Warrant Applications and Warrants

may be available from ORA/DE,

oraospopenforcementdivio@fda.hhs.gov.

3. Processing

The lead coordinator should transfer the case to DE by

changing the current owner to DE pursuant to CMS procedures. 

CMS will automatically send an e-mail to the person in DE

designated to receive notification when actions have been

submitted to that office. Prior to changing ownership for

submission of the action, the lead coordinator should identify all

adulteration and/or misbranding charges cited in the subject

action under the Act/CFR tab in CMS.
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The lead coordinator will promptly alert DE of copies of

approved, filed warrants uploaded in CMS and keep DE

informed of the progress of the inspection under the warrant.

DOJ prefers, and FDA encourages, that U.S. Marshals

accompany FDA investigators when warrants are executed. If

this presents a problem for ORA staff, DE should be notified

immediately. The recommending PDD should anticipate and set

forth in the cover memorandum any situation that may result in

a refusal or delay of an inspection conducted under a warrant.

Whenever possible, an agency decision and implementation

strategy regarding anticipated resistance, possible arrests, or

use of force during execution of the inspection warrant should

be considered and made prior to execution of the warrant.

If problems are encountered during the application for or

execution of the warrant, DE should be contacted immediately.

If there is a legal issue, contact OCC and DE immediately. A

return (a statement indicating completion of the inspection

conducted under warrant) must be made to the Court within 10

days of completion of the inspection. The return is a separate

document prepared as part of the draft warrant application. It is

simply a statement from the Investigator who was authorized to

conduct the inspection that the inspection was made on a

certain date(s). The document is filled in with the date of

inspection, signed by the Investigator, and returned to the Court.

A copy of the return should also be uploaded into CMS and a

hardcopy should be forwarded to OCC.

B. Division of Enforcement (DE)

When a recommendation for an inspection warrant is transferred

from the Program Division to DE, DE maintains case ownership but

will send a task in CMS to the responsible Center(s) for concurrent

review. The Center and DE will review the recommendation and

proposed documents to assess the need for the action, the

agency's statutory authority, completeness, accuracy, format, and

conformance with current DOJ requirements. The Center indicates

the completion of their review by uploading associated documents

into CMS and closing the “task” pursuant to procedures in CMS. 

DE will provide the revised documents to OCC. Throughout the

process, DE will monitor and coordinate the concurrent review and

processing of the inspection warrant with the recommending

Program Division, Center, and subsequently with OCC, and DOJ. If

a warrant application is not approved by DE, a written explanation

of the decision will be uploaded into CMS and DE will indicate

“Non-Concur” in the internal decision field with the reason for nonconcurrence, adding the completed date and changing the current
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owner to the program or division, as appropriate. The office should

close out the case pursuant to CMS procedures.

If through concurrent review by the Center and DE, a warrant

application package is approved, DE will revise the documents as

needed, upload them into CMS and indicate “Concur” in the internal

decision field and add the completed date. DE will forward the

revised documents to the Deputy Chief Counsel for Litigation, OCC

and a draft DOJ transmittal memorandum for OCC. After review

and approval of the warrant application package by OCC, OCC will 

forward the application package to DOJ and provide the final 

package to DE for upload to CMS. DE will update the FDA Final 

Decision to Approved.

Following DOJ review, DE uploads into CMS the DOJ approved (or

denied) warrant application package, including any necessary

guidance or instructions for the application and execution of the

warrant. DOJ coordinates the filing of the application warrant with 

the Assistant U.S. Attorney’s Office. Action ownership in CMS will

end with DE.

DE notifies the Director of Office of Strategic Planning and 

Operational Policy (OSPOP) who notifies the Associate

Commissioner for Regulatory Affairs (ACRA) through the Assistant 

Commissioner for Partnerships and Policy (OPOP) and designated

contacts in the FDA Office of External Affairs and Office of Media 

Affairs of the strategy and impending action immediately once DOJ 

agrees to file the application and the filing has occurred or is 

imminent. DE uploads into CMS the files of all warrant

recommendations. OSPOP/DE ensures the ACRA is notified once 

the inspection warrant has been executed.

C. Center

The responsible center promptly reviews all warrant application

documents forwarded to it by DE, ensuring center support (or

providing reasons for disapproval) and the accuracy of statutory

references, with special emphasis on the authority for access to

those items sought to be inspected. Where possible, revisions to

documents should be highlighted and uploaded into CMS.

Disapprovals are documented in writing and uploaded into CMS

over the signature of the Director, Office of Compliance, or his/her

designee.

D. Office of Chief Counsel

OCC promptly reviews the warrant and application package for

legal sufficiency and transmits the final application package to DOJ.

Any disapprovals will be documented in writing and DE will upload

them into CMS.
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6-4 SEARCH WARRANTS

6-4-1 Purpose

To provide the procedures for obtaining search warrants. Procedures for

Inspection warrants in RPM Section 6-3.

6-4-2 Search Warrants

Search warrants are effective tools for obtaining evidence of criminal

conduct, and for seizing contraband or the fruits of a crime, property that

has been or is intended to be used in the commission of a crime, or the

arrest of persons based upon probable cause. See Rule 41, Federal Rules

of Criminal Procedure. Also, see U.S. Attorney's Manual. Criminal search

warrants are particularly useful when there is reason to believe that

relevant evidence may be hidden or destroyed.

6-4-3 Procedures

The Office of Criminal Investigations (OCI) is responsible for reviewing all

matters in FDA for which a criminal investigation is recommended and is

the focal point for all criminal matters. ORA management must

communicate with its local OCI office, as instructed in subsection 6-5-10

“Referral of Criminal Matters to the Office of Criminal Investigations”

below, before pursuing a criminal search warrant.

6-5 PROSECUTION

6-5-1 Purpose

This section establishes operational procedures for the uniform

submission and review of prosecution recommendations, including

referrals for criminal investigation. A number of different procedures,

depending upon the distinguishing case features, are included in order to

eliminate unnecessary review and to expedite the case review process.

As described below, all criminal referrals, whether initiated by ORA, the

Center, or another FDA Headquarters component, must be sent to OCI for

initial review in accordance with this section. If OCI declines the referral,

the Center or ORA may pursue the matter through the preparation of a

Summary and Recommendation in accordance with subsection 6-5-5 et

seq.

6-5-2 Referral of Criminal Matters to the Office of Criminal Investigations

OCI is responsible for reviewing all matters in FDA for which a criminal

investigation is recommended and is the focal point for all criminal

matters. FDA personnel must refer all criminal matters, regardless of their
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complexity or breadth, to OCI. This includes criminal search warrants,

misdemeanor prosecutions, felony prosecutions, referrals for criminal

investigation, and meetings associated with section 305.

ORA management must communicate with the local OCI office before

pursuing any criminal matter. Designated center and ORA and FDA

Headquarters points of contact must communicate with their respective

OCI Senior Operations Manager (SOM). This communication is absolutely

essential to preclude potential interference with other on- going criminal

investigations and to prevent confusion among the components of OCC

and DOJ that are responsible for handling FDA’s criminal cases.

During this communication, OCI is to be provided with all of the facts of

the potential case and any additional information that is relevant to, or

could impact, the case in any way. In accordance with SMG 9111, ORA

management should notify the local Special Agent in Charge (SAIC),

Assistant Special Agent in Charge (ASAIC), or Resident Agent in Charge

(RAIC) of the referral via telephone. For referrals of Park Doctrine

prosecutions, see the procedures below.

For all criminal referrals, OCI will decide promptly whether or not to pursue

the case.

OCI will communicate its decision back to the referring Office. If OCI

declines to pursue a referral, OCI will promptly convey its decision to the

referring office, which may then proceed with the case and submit a formal

summary and recommendation for prosecution in accordance with

subsections 6-5-5 and 6-5-13 of this chapter.

6-5-3 Special Procedures and Considerations for Park Doctrine Prosecutions

A. Recommending Park Doctrine Prosecutions

The Park Doctrine, as established by Supreme Court case law,

provides that a responsible corporate official can be held liable for a

first-time misdemeanor (and possible subsequent felony) under the

Act without proof that the corporate official acted with intent or even

negligence, and even if such corporate official did not have any

actual knowledge of, or participation in, the specific offense. A Park

Doctrine prosecution, for the purposes of this section, refers to a

recommended prosecution of a responsible corporate official for a

misdemeanor violation of the Act.

Misdemeanor prosecution under the Act can be a valuable

enforcement tool. Such prosecutions are referred to DOJ. Once a

person has been convicted of a misdemeanor under the Act, any

subsequent violation of the Act is a felony, even without proof that

the defendant acted with the intent to defraud or mislead.

Misdemeanor prosecutions, particularly those against responsible

corporate officials, can have a strong deterrent effect on the
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defendants and other regulated entities. In some cases, a

misdemeanor conviction of an individual may serve as the basis for

debarment by FDA.

1. When considering whether to recommend a misdemeanor

prosecution against a corporate official, consider the individual’s

position in the company and relationship to the violation, and

whether the official had the authority to correct or prevent the

violation. Knowledge of and actual participation in the violation

are not a prerequisite to a misdemeanor prosecution but are

factors that may be relevant when deciding whether to

recommend charging a misdemeanor violation.

2. Other factors to consider include but are not limited to:

a. Whether the violation involves actual or potential harm to the

public;

b. Whether the violation is obvious;

c. Whether the violation reflects a pattern of illegal behavior

and/or failure to heed prior warnings;

d. Whether the violation is widespread;

e. Whether the violation is serious;

f. The quality of the legal and factual support for the proposed

prosecution; and

g. Whether the proposed prosecution is a prudent use of

agency resources.

As the Supreme Court has recognized, it would be futile to attempt

to define or indicate by way of illustration either the categories of

persons that may bear a responsible relationship to a violation or

the types of conduct that may be viewed as causing or contributing

to a violation of the Act. In addition, these factors are intended

solely to explain the focus for the procedural steps to be addressed

by FDA personnel, and do not create or confer any rights or

benefits for or on any person, and do not operate to bind FDA.

Further, the absence of some factors does not mean that a referral

is inappropriate where other factors are evident.

When ORA is considering initiating a referral for a Park Doctrine

prosecution, the lead coordinator is required to consult with the

appropriate center to ensure that the referral will align with agency

priorities and that the center will support the referral and provide

expert witnesses or other litigation support when necessary.

Centers and ORA offices are also encouraged to consult with OCC

and OCI HQ SAIC and/or the ASAIC Investigative Operations

Division (IOD) early in the process for guidance and

recommendations regarding optimal venue.
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If ORA or the center is seeking a misdemeanor prosecution under

the Park Doctrine, the initial referral to OCI should clearly indicate

that a Park Doctrine prosecution is being sought and the reasons

that a Park Doctrine prosecution would be beneficial. At the same

time that ORA refers a Park Doctrine prosecution to the appropriate 

OCI Office, notice of the referral also should be sent to the SAIC

and/or the ASAIC OCI HQ IOD, and the applicable center. Notice of

all Park Doctrine referrals, whether initiated by the office or the

center, should also be sent to the Deputy Chief Counsel and

Associate Deputy Chief Counsel for Litigation in OCC, and to the

director of DE.

Upon receipt of a Park Doctrine referral, OCI will promptly review

the referral and will communicate with OCC and the referring office

to obtain any information or assistance needed to present the

matter for prosecution. In appropriate cases, the assigned OCC

attorney and/or a representative from DE or other component

should participate in the initial presentation of the Park Doctrine

matter.

6-5-4 Communication Between OCI and Other FDA Components

The following Staff Manual Guides (SMGs) provide additional information

on communications between OCI and other FDA components:

A. SMG 9111 Sharing of Information Related to Criminal Violations.

This SMG requires that OCI be notified of potential criminal activity

immediately if there is an imminent threat to public health and

within 10 business days in all other cases and that OCI evaluate

the information within 10 business days and notify the office of its

initial assessment. It also addresses information sharing between

OCI and other FDA components.

B. SMG 9110 Enhanced Communications with the Office of Criminal

Investigations (OCI) and Improved Alignment of

Criminal/Regulatory Priorities and Activities. This SMG provides

general procedures for the establishment of regularly scheduled

meetings between OCI and center, ORA and other FDA

components.

Notify OCI if you receive a request from a law enforcement agency

(federal, state/local, or foreign) for non-public information related to a

criminal case. Notification should be provided to the SAIC and/or the

ASAIC, OCI HQ IOD. This is particularly important if the request relates to

grand jury information, judicial proceedings under the Act, or joint

investigations with OCI and other law enforcement agencies about

violations of the Act. When OCI seeks non-public information on its own

initiative or in response to a request described above, provide the

information to the SAIC and/or the ASAIC OCI HQ IOD for their review
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and determination of appropriate written confidentiality assurances prior to

disclosure. Indicate what information is non-public.

6-5-5 Processing a Summary and Recommendation

In cases where OCI has declined to pursue a referral, the

recommendation for prosecution or for investigation with a view of

possible criminal charges will be prepared in the format of a Summary and

Recommendation (S&R). This document is a memorandum containing all

information that would permit review and evaluation of the office's

recommendation, including the reasons for not including samples or

individuals cited in the Section 305 notice (when such a notice is issued)

and information concerning any potential weaknesses in the case,

anticipated defenses, or reasons why discretion may be exercised not to

prosecute a person (such as, extreme age or very poor health).

It is important for the S&R to contain all facts pertaining to the

recommendation, since it will be relied upon to determine whether a case

is prosecutable and worthy of forwarding to DOJ. In prosecution cases in

which FDA forwards counts in an Information or Indictment (as opposed to

referrals for criminal investigation), the S&R should present the evidence

of each element of the offense to be charged.

Where a lead coordinator submitted the original referral or where the

referral relates to an inspectional process, each recommendation must be

accompanied by the written concurrence of the DD and the Director of DE.

The DD's approval must state why prosecution is the action of choice, and 

DE must concur. This concurrence will appear on the last page of the

S&R. Where a center submitted the original referral and the referral

relates to a center process, each recommendation must be accompanied

by the written concurrence of the director of the center’s office of

compliance.

See subsection 6-5-13 for detailed guidance for preparing an S&R.

6-5-6 Criminal Prosecution after Section 305 Notice

Criminal referrals for which the agency has provided a notice and

opportunity to respond, pursuant to Section 305 of the Act, should follow

the procedures described below:

A. When ORA does not have direct reference authority to issue a

Section 305 notice, ORA will submit a citation recommendation to

the appropriate center(s) for review, after contacting OCI (as

described in “Referral of Criminal Matters to the Office of Criminal

Investigations” in subsection 6-5-2 above.

Generally, the citation recommendation includes:

1. the names and responsibilities of each individual and the

charges to be presented in the notice;
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2. the full background history of notification of the persons to

receive a notice; and,

3. facts supporting the proposed charges, including assurance of

interstate documentation. All pertinent evidence, such as work

sheets, labels, and inspection reports, should be submitted with

the recommendation. The center may request the interstate

documentation if a special need to review it exists.

B. If ORA or the center identifies an issue requiring consultation with 

DE, OCI, OCC, or an ad hoc committee, the component identifying

the issue will obtain prompt resolution as early in the review

process as possible.

C. If, following the meeting held in response to the Section 305 notice,

there is no significant change in the facts, as set forth in the citation

recommendation, the lead coordinator will notify the center, which

will promptly forward the citation recommendation package to DE.

Concurrently, a final S&R will be sent by the lead coordinator to DE

with copies to the center.

If there is a significant change in the facts or strength of the

proposed case, the lead coordinator will submit the prosecution

recommendation package to the appropriate center solely to

determine whether prosecution remains warranted in view of the

new information. If prosecution is warranted, the center will

promptly forward to DE the prosecution S&R and the center's

approval memo presenting the basis for its decision in light of the

new information.

NOTE: When ORA has evidence sufficient to meet the

requirements for direct reference authority to issue a Section 305

notice ("direct reference cite authority"), the procedures in # 1

above do not apply (except that OCI must be contacted, as

described in “Referral of Criminal Matters to the Office of Criminal

Investigations” above). After the Section 305 process has been

completed and, if no new information is presented that affects the

basis for the direct reference authority, the lead coordinator should

promptly submit its prosecution S&R directly to DE for a limited

review. The lead coordinator should concurrently send a copy of

the S&R to the center.

If the response to the Section 305 notice reveals new information

affecting the basis for the direct reference cite authority, the PDD

must obtain center review and concurrence concerning that aspect

of the recommendation before submitting it to DE.

D. DE will perform a limited review to determine whether the proposed

prosecution conforms to agency policy and enforcement strategies

and objectives. If DE concurs in the prosecution recommendation, it
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will forward all relevant materials to OCC, along with a memo

concerning the issues it has considered and that DE believes OCC

should review.

E. OCC will review the recommendation and, if it agrees that

prosecution is supportable, prepare a referral letter and form of

Information or Indictment.

6-5-7 Criminal Prosecution without Section 305 Notice

Those instances in which the agency need not issue a Section 305 notice

under the Act are codified in 21 CFR 7.84. No Section 305 notice is

required in cases brought under Title 18 of the United States Code - as

opposed to cases brought under the Act - or in cases exempt under 21

CFR 7.84(a)(2) and (3), based on the agency's belief that the notice might

result in alteration or destruction of evidence or flight to avoid prosecution.

Nor is a Section 305 notice usually provided when the agency is

recommending further investigation.

Criminal referrals not preceded by a Section 305 notice should follow the

procedures described below. OCI must be contacted early on in this

process, in accordance with the procedures described in “Referral of

Criminal Matters to the Office of Criminal Investigations” above.

A. The PDD is to consult with DE, which will consult with OCC, to

determine whether to issue a Section 305 notice or whether an ad

hoc committee is needed to decide the issue. If DE and OCC agree

that no Section 305 notice should be issued, DE will so notify the

director. The lead coordinator will then prepare an S&R and obtain

approval from the Region before submitting the S&R to DE, with

concurrent copies to the center and OCC for review. The lead 

coordinator will explain under the heading "No Section 305 Notice"

why such notice is not required. Should DE and OCC decide that a

Section 305 notice should be issued, DE will so notify the lead 

coordinator who will then follow the procedure under RPM

subsection 6-5-6, "Criminal Prosecution after 305 Notice".

B. If the center and DE concur in the recommendation, each will

prepare a memo reflecting its views on the relevant issues. The

center will forward its memo to DE.

C. DE will forward all relevant materials and memos to OCC and if

OCC agrees that prosecution is supportable OCC will prepare a

referral letter and form of Information or Indictment.

6-5-8 Contempt of Court; Violation of Probation

The lead coordinator will prepare an S&R outlining the facts that establish

the violative conduct and send it and a copy of the pertinent court order

electronically via CMS to DE. Because DE and the relevant center are
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expected to conduct concurrent reviews, the S&R should include a

request that DE send a task referral pursuant to CMS procedures to the

center requesting its review.

Both the center and DE will have 10 working days to review the proposed

action and upload their comments into CMS.

If no adverse comment is provided by either the center or DE, or if

adverse comment was provided but a consensus to proceed is reached,

the lead coordinator will forward its S&R and supporting evidence to DE

via CMS for prompt forwarding to OCC for review. If OCC agrees that the

action is supportable, it will prepare a referral letter.

6-5-9 Development of Felony Violation

Some investigations may reveal facts supporting potential felony charges

under either Title 18 of the United States Code or 21 U.S.C. 333(a)(2). A

primary problem associated with these cases is determining the

investigational end-point. When such situations are encountered, an ad

hoc committee should be considered. This is because some potential

cases should be referred at an early stage for a grand jury investigation,

while FDA can carry others to investigational completion prior to referral.

The following matters, among others, should be considered in these

situations:

A. scope of the investigation;

B. status of current investigation, including identification of targets and

of potential cooperating individuals;

C. strategy and timing in completing the investigation;

D. agency compliance policy in the area at issue;

E. preliminary evidence that violations are intentional;

F. identification of inspectional or investigational problems;

G. use of criminal search warrants;

H. need for or wisdom of a Section 305 notice citation; and,

I. recommendation for grand jury investigation. See subsection

6-5-12, "Grand Jury Investigations and Secrecy".

For investigations subject to ad hoc committee oversight, the compliance

branch in the managing organizational unit will prepare a status report

whenever significant progress is made on an investigation or at least

every 90 calendar days, whichever occurs first, and distribute it to DE,

OCC, appropriate center, and affected program/division offices.
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6-5-10Referrals for Criminal Investigation

A referral from ORA or center to DOJ for further criminal investigation,

including an investigative grand jury, should follow the process described

below:

A. The initiating unit, division or center, will notify OCI in accordance

with the RPM section "Office of Criminal Investigations." If OCI

elects not to pursue the case, then the unit or center may notify DE

and request an ad hoc committee meeting and provide a Summary

and Recommendation Document (S&R) of the existing evidence.

Relevant, organized, and tabbed background material will be

assembled by the initiating unit and uploaded with the S&R into

CMS. The lead coordinator should transfer the case to DE by

changing the current owner to DE pursuant to CMS procedures.

CMS will automatically send an e-mail to the person in DE

designated to receive notification when ownership of a case has

changed to that office. Information should cross reference and cite

specific pages of the background material.

B. Prior to scheduling the meeting, DE will review the background

package and ensure that it is in a form that will facilitate review and

identification of issues.

C. DE will promptly notify the committee via e-mail of the availability of

the background package in CMS and in the body of the e-mail

provide a time and place for the meeting and identify the principal

issues to be decided. With very rare exception, a minimum of 10

working days will be provided for members to review the

background package; center review will be given high priority and

the meeting will not be scheduled until the center is ready to

participate. A copy of this e-mail should be uploaded into CMS.

D. The committee members should be prepared to make agency

decisions on the issues, including whether referral should be made

on the basis of the evidence in hand, whether additional

assignments should first be issued, completed, and reviewed by the

committee, or whether a noncriminal disposition should be

considered in lieu of or in addition to a prosecution.

E. Should the committee members concur in the recommendation for

referral and believe that there is no need to gather further evidence

or for a further meeting, DE will promptly prepare a memorandum

of the decision, upload it into CMS and forward a hardcopy to OCC

as the agency's recommendation. DE will maintain ownership of the

case. OCC will revise ORA’s draft of the referral letter, as

necessary. DE should upload this draft into CMS.

F. Should the committee believe that additional investigation is

needed, the committee will issue the appropriate assignments,
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record them in a memo that is uploaded in CMS and set a tentative

date to reconvene. Offices performing the additional work will be

responsible for providing written summaries of the results and,

when appropriate, recommendations to the committee in advance

of the next meeting. These associated documents should be

uploaded into CMS. DE will monitor the status of the assignments

and schedule via e-mail the follow-up meeting. A minimum of 5

working days will be provided for members to review new

information prior to the meeting. DE will prepare a memorandum of

any subsequent meeting and upload it into CMS.

G. If the committee decides, either on the basis of its initial review or

on the basis of additional data discussed at a subsequent meeting,

that a request for criminal investigation should be referred, DE will

promptly forward to OCC any relevant materials that may not have

previously been provided along with a written request that OCC

refer the matter to DOJ.

NOTE: When FDA participates in investigations in which another

Federal agency has the lead and intends to request a criminal

investigation, ORA will work directly with the lead agency in developing

evidence and in assisting in the investigation. In such cases, the lead 

coordinator will promptly notify the relevant centers, ORA program and 

division, DE, OCI, and OCC of the investigation, the roles of the units 

in the investigation, and whether a grand jury investigation is

contemplated.

As soon as the lead coordinator determines that it would like to seek

the prosecution of Title 21 or Title 18 charges based upon violations

involving FDA regulated articles in an investigation where another

Federal agency has the lead, it will notify DE, for an FDC number, the

centers, and OCC of its intent to do so and will promptly forward a

recommendation to DE, the center or, if appropriate, directly to OCC,

to obtain approval to proceed with the case.

In some cases, an ad hoc meeting may be appropriate. If special time

constraints are applicable because of the participation of other

agencies, the recommendation should so state. Except for possible

time constraints, joint investigations should be processed in the same

manner as other FDA cases.

6-5-11Information and Indictments

These documents will usually be prepared by Office of Chief Counsel.

An Information is the formal legal document that is usually used to allege

misdemeanor violations. An Indictment is the document in which felony

violations are alleged, following presentation to the grand jury. This

document is also referred to as a True Bill of Indictment. With the consent
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of a defendant, an Information may be presented to a grand jury, even

though only misdemeanor violations are alleged.

6-5-12Grand Jury Investigations and Secrecy

Grand jury investigations are subject to Rule 6 of the Federal Rules of

Criminal Procedure. See Exhibit 6-28. The fact of grand jury investigations

and the actions of a Federal grand jury are secret. Only persons whose

names have been filed with the court pursuant to Rule 6(e) may know

about the grand jury's activities, such as whether the grand jury has issued

a subpoena to someone. For this reason, transcripts of testimony

given before a grand jury can be read by or discussed only with

persons who have been designated under Rule 6(e). Neither FDA

colleagues nor supervisors may be advised of the substance of

grand jury activities unless they have been designated under Rule

6(e).

As with any pending investigation, there should be no comment

whatsoever to the media or to the general public about the existence or

activities of a grand jury. Even if there has already been speculation in the

press about a grand jury or reports about it from witnesses called to testify

before the grand jury (who are not bound by the rule of grand jury

secrecy), no confirmation or other comment on the grand jury should be

made.

Strict adherence to the rule of grand jury secrecy protects not only the

integrity of the government's investigation and the validity of any

indictment the grand jury might return, but the rights of the persons

accused.

Compromising the 6(e) rule is a very serious matter and could result in

dismissal of the charges, the suppression of valuable information, and/or a

contempt citation against persons violating Rule 6(e).

DOJ and the U.S. Attorney may request FDA to provide investigative

support to conduct interviews, accompany U.S. Marshals to seize

evidence, and so on. Any person who is involved in this type of

investigation will be given a 6(e) designation where these actions involve

matters occurring before the grand jury.

6-5-13Preparation of Summary and Recommendation

See Exhibit 6-24 for a model format for the summary and recommendation

memorandum and Exhibit 6-25 for an example of a food sanitation case.

The Sample Index is an outline of the support samples related to the

prosecution.

A. Sample Number, Product, Date Shipped

The order of the counts in an Information or Indictment is variable,

but should be determined by the significance or seriousness of the
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violations, rather than the sequential order of the sample numbers

or the date of sample collection. However, where all samples or

schemes have the same degree of seriousness, list in descending

chronological order (most recent offense in Count I, next most

recent offense in Count II, and so forth. The column headings may

be changed to provide whatever information ORA feels is

significant. Beneath the sample number indicate the proposed

count number. In cases where supporting samples are

unnecessary, describe the scheme or violation and outline the

elements of the offenses.

B. Citation Under Section 305 Of The FD&C Act

List complete names and addresses of all persons issued Section

305 notices. Prepare brief, concise paragraphs explaining

significant new evidence obtained since the Recommendation for

Citation was submitted. Also include any changes in the status of

responsible individuals or the firm that have occurred since the

center approved the issuance of 305 notices or, in the case of

direct reference cite authority, since the Section 305 notice issued.

See subsection 6-5-6 "Criminal Prosecution after Section 305

Notice”. If this is a recommendation without a Section 305 notice,

prepare a brief paragraph explaining the facts, including identifying

the basis of concurrence with this approach, for example, "Ad Hoc

meeting."

C. Legal Status

Prepare a brief paragraph describing the legal status of the firm as

of the date of the S&R and at the time of the violations. If there has

been a change in the legal status in the interim, furnish complete

information concerning the change. As soon as the decision is

made to recommend prosecution of a corporation, request certified

copies of the Articles of Incorporation and the most recent Annual

Corporate Registration. The annual corporate registration may list

the current corporate officers at the date of filing. This request may

be made in writing as shown in Exhibit 6-26 or in person so that the

records are received in a form suitable for introduction into

evidence (see Exhibit 6-28). If the Articles of Incorporation have

been received before the recommendation has been submitted, so

state in this section and enclose photocopies of the Articles with the

recommendation. If they have not been received, include a

statement that the Articles of Incorporation have been requested

and photocopies will be submitted upon receipt.

When preparing photocopies of certified copies, the removal of any

staples nullifies the certification. -- Caution the Legal

Secretary/Technician about this.
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If a corporation is dissolved, in most states it still legally exists for a

period of time specified by the state in which it is incorporated and

may be prosecuted during that period. In case of dissolution, submit

copies of any notices thereof filed with the state and reports of any

actions by the state on such dissolution.

D. Alleged Violation

Prepare a summary of what the case is about. Include a statement

on how the problem came to the attention of the agency. List the

violations under this heading. In the event the proposed counts are

numerous, and the violations involve several different sections of a

statute, you may use an outline or tabular form. Adulteration and

misbranding charges should be charged in separate counts. In

cases involving fraud, a detailed statement of all pertinent data

(who, what, when, where, why, and how) concerning the scheme,

from its conception through its perpetration, should be prepared.

The following questions should be considered:

1. When was the scheme initially implemented? By whom?

2. What were its primary objectives?

3. What were the methods by which it was implemented?

4. Where was it put into operation and for how long?

5. What was the nature of the scheme, the types of merchandise

or service involved?

6. Describe the magnitude, nature, and characteristics of the

scheme (for example, number of units shipped, and amount of

money involved).

7. Describe the victims as to health, economic status, or other

features.

8. Identify for each proposed defendant or target any evidence

reflecting that the offense was committed knowingly and willfully

(intentionally).

9. Identify potentially cooperative witnesses.

10.Describe any noteworthy investigational problems encountered.

E. History

State briefly the regulatory history of the firm and the individual

defendants. Point out any cooperative work FDA has done with the

state or other Federal agencies. Indicate any prior Federal action

and any state legal action taken against the proposed defendants

as well as any previous in rem actions.
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F. Prior Notice

As more fully explained in RPM Chapter 10 - Other Procedures

when it is consistent with the public protection responsibilities of the

agency and if a violative situation does not present a danger to

health or does not constitute intentional, gross or flagrant violations,

it is FDA’s policy to afford individuals and firms an opportunity to

voluntarily take appropriate and prompt corrective action prior to the

initiation of enforcement action. If voluntary correction is not

achieved, documentation that adequate prior notice was provided

strengthens the agency’s position in enforcement actions by

establishing that responsible individuals continued violating the law

despite having been warned by the agency.

Indicate how and to whom prior notice was provided. If formal prior

notice has not been given, indicate how the proposed defendants

are aware of the consequences of their violative acts, or explain

why prior notice is not necessary or appropriate in this situation.

G. Other Correspondence

Provide reference to and copies of any correspondence that the

agency (division, program, center, or other headquarters' unit) and

state may have regarding matters subject to the recommended

action.

H. Witnesses for Inspectional and Analytical Findings

Arrange the samples (if any) by proposed count numbers listing the

collecting investigator and the analysts. Identify the documentary

and physical evidence associated with each witness and describe

how this evidence was obtained, e.g., interview, inspection,

surveillance, or other means. For a case with support samples,

assign count numbers as in Exhibit 6-25.

I. Other Witnesses

List the names, addresses, telephone numbers, and titles of any

other known witnesses, including cooperating subjects of the

investigation, FDA representatives from the center, and

nongovernment expert witnesses with a summary of their

anticipated testimony.

J. Recommendation

List the persons being recommended for prosecution and the

corresponding sample numbers (if any) or scheme that is the basis

for prosecution. If any such persons have been previously

convicted or are the subject of other legal action, include a

paragraph stating the nature of the charge, the date the case was

terminated, the disposition, the penalty imposed, the jurisdiction,

and the case number (and an FDC, lead sample, or other FDA
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identifying numbers, if any). Indicate whether warnings were given

and summarize the recommended defendant's response or

corrective action. Indicate what harm has or can result from the

criminal activity at issue, such as, type and total amount of loss,

number and type of victims, and similar information. See also the

RPM Chapter 10 - Other Procedures, subsection 10-2 Prior Notice.

K. Permanent Abeyance of Samples or Non-Inclusion of Individuals

If ORA decides to place any of the samples listed in the Section

305 notice in permanent abeyance or to not include cited

individuals as proposed defendants, the reasons for these

decisions should be given in this section. Excluded samples should

not be destroyed until the termination of the action by plea or trial. If

all samples and individuals listed in the Section 305 notice are

included in the prosecution recommendation, this section may be

omitted.

L. Sample Data

This section is designed to furnish a brief summary of the available

information in the file regarding each sample. Ordinarily, a criminal

case should include more than one count and only in very unusual

circumstances, which must be explained in the memorandum, will a

one-count Information be referred to DOJ.

Thoroughly discuss any potential problem areas with respect to the

samples, such as a modification of official analytical methods

during analysis, deviations from normal procedures in the collection

of the samples, errors in the collection records, seals, analytical

records which had to be corrected, or any inconsistencies between

affidavits and records.

1. Date lot shipped/received: For 301(a) or (d) violations, state the

date the defendants shipped the lot or delivered it for shipment.

For 301(k) violations, state the date the defendants received the

lot, and for 301(c) violations state the date the lot was received

and the date it was delivered or proffered for delivery.

Occasionally, the receiving date in a 301(k) violation is not

available. In such a case, the date of the offense is the day on

which the investigator can testify that she or he saw the subject

lot at the proposed defendant's premises. Occasionally, a 305

notice will issue with the date of shipment being the date

furnished in an affidavit signed by the dealer, but subsequent

investigation uncovers records indicating that the lot was

actually shipped or delivered on another date. As long as the

305-notice stated "on or about" with respect to the date, this is

acceptable. The correct date will be listed in the Information or

Indictment, even if it differs from that listed in the Section 305

notice. Complete information regarding the conflicting dates
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should be furnished under the caption "Documentation of

Interstate Commerce."

2. Date lot sampled/by whom: If the sampling of the lot takes place

over a period of several days, that should be stated here. In the

case of a 301(k) violation, if the lot remains in the regular

storage area for saleable goods, the Information or Indictment

will indicate that it was held for sale between the date of receipt

and the last day of the inspection. If the lot is moved to a

quarantine area and it is clear that it is not to be sold, the day

the product was moved (or destroyed, denatured, or

embargoed) will be used in the Information or Indictment. In

addition to the name of the collecting investigator, indicate

where he or she is located at the time of the writing of the

recommendation. If the investigator has transferred to another

district, resigned, or retired, he or she should be contacted when

the Information or Indictment is submitted to DOJ, advised that

prosecution is pending, and requested to keep the PDD

informed of his or her location so that the investigator can be

contacted if the case goes to trial.

3. Description of lot and sample size: The size of the lot should be

listed and, in 301(k) sanitation cases, a brief description of the

lot should be given.

For example, the description should contain the statement that

the investigator looked at (number of) bags, found urine on

(number of) bags, (number of) bags were rodent gnawed, and

should indicate whether filth was only on the exterior of the lot or

on containers covered by other containers, whether or not the

lot was received palletized, whether containers in the lot had

been restacked by the firm, etc.

4. Analysts: As with the collecting investigator, the current location

of the analysts should be recorded and contact should be made

with the analysts when the Information or Indictment is

submitted to DOJ.

5. Analytical methods: The method of analysis should be given. If

there was any deviation from an official method, complete

information concerning the modification and reasons therefore

should be given. In the analysis of official preparations, the

method in the compendium should be followed.

6. Number of subs analyzed: If every sub has been analyzed,

merely state "all." It is incumbent upon the Compliance Branch

to ensure that sufficient analytical work has been performed.

7. Analytical findings: The results of each analysis of the product

should be listed. If the problems which were encountered

necessitated additional work, or deviation in or from an official
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method such as new methodology or analysis to resolve

discrepancies in analytical results, such matters should be

disclosed and discussed. In cases involving filth in foods, the

analytical findings should be broken into two groups; those

demonstrating actual contamination in the product [402(a)(3)]

and those demonstrating 402(a)(4) conditions.

The results regarding the findings of actual product

contamination should be summarized basically as follows:

a. Section 402(a)(3) Verification

Subs,__________, and - gnawed -incisor marks - confirmed.

Subs,__________, and- contained rat or mouse excreta or

hair - confirmed.

Sub - insects (identities, if possible)

b. Section 402(a)(4) Verification

If there is substantial 402(a)(3) evidence, the subsamples

collected from the surface and proximity of the lot need only

be briefly summarized, covering each type of 402(a)(4) filth

present. This includes rat or mouse excreta, rodent urine,

and rodent nesting material as being confirmed or identified.

If the proposed charges differ from the data listed under

"Analytical Findings" or the charge sheet that accompanied

the 305 notice, the reasons for the differences should be

discussed.

8. Section 702(B) Portion: In any case involving analytical work, a

portion of the sample usually should` be available for the

defendant, should he or she request it. Verify whether the

section 702(b) sample portion is available, and note the amount

available. If a 702(b) portion does not exist, this fact should be

conspicuously noted, and an explanation provided.

Some exceptions to the requirement for 702(b) portions are

codified at 21 CFR 2.10. If all subs have been analyzed, there is

a presumptive 702(b) concern which should be addressed.

NOTE: Filth exhibits do not require a 702(b) portion.

9. Seizure: If the lot forming the basis for a proposed count was

seized, list the case number and the FDC number and state the

disposition of the seizure.

10.Documentation of interstate commerce: State the name and title

of individuals signing dealer statements and affidavits, the name

and address of the firm for which they work, and list the

documents furnished, including information such as purchase

order, invoice, freight bill, and bill of lading numbers, and the
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dates they were issued. Interstate commerce witnesses are

sometimes called on to testify and supply the original

documents in the event the case goes to trial.

11.Remarks: This section should contain detailed information

concerning any potential problem areas or weaknesses in the

case not covered in the description of the individual counts.

Include the ages of the proposed defendants and, if known, any

physical problems they may have. Also, indicate that OCI was

contacted regarding the case. Finally, state why prosecution is

the action of choice.

6-5-14Submission of Summary and Recommendation Documents

The summary and recommendation (S&R) documents are submitted to

the center, DE and OCC, depending upon the instructions described in the

applicable case procedure in subsections 6-5-6 "Criminal Prosecution

after Section 305 Notice," 6-5-7 “Criminal Prosecution Without Section 305

Notice", or 6-5-2 "Referrals of Criminal Matters to OCI for Criminal

Investigation."

A. Prosecutions Requiring Center Approval

1. Submit the S&R (prepared as described in “Preparation of

Summary and Recommendation”) and the supporting

documents listed below by uploading them into CMS.

a. Section 305 Notice and Charge Sheet

b. Record of Section 305 meeting and any documents

presented at the meeting

c. Written answer to the Section 305 notice (if meeting was not

held)

d. Any correspondence or memoranda of telephone

conversations with proposed defendants since the Citation

Recommendation was submitted.

e. Guaranty (if applicable)

f. Articles of Incorporation (Photocopy can be submitted in

CMS and lead coordinator will maintain the original. DO

NOT HOLE PUNCH the original document).

Centers should upload their approval memo into CMS.

NOTE: If the recommendation meets the circumstances outlined

in subsection 6-5-13 "Processing a Summary and

Recommendation" and does not require further review by the

center, submit the S&R and supporting documents to DE as

described in “Direct Reference Prosecutions” below.
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B. Direct Reference Prosecutions

The S&R prepared as described in subsection 6-5-13 "Processing a

Summary and Recommendation" should be uploaded into CMS.

The lead coordinator should transfer the case to DE by changing

the current owner to DE pursuant to CMS procedures. CMS will

automatically send an e-mail to the person in DE designated to

receive notification when ownership of a case has changed to that

office. The S&R should contain the supporting documents listed

above.

6-6 CIVIL PENALTIES – ELECTRONIC PRODUCT RADIATION CONTROL

6-6-1 Purpose

This section provides procedures and instructions for recommendations of

civil penalties for violations of Subchapter C - Electronic Product Radiation

Control (formerly the Radiation Control for Health and Safety Act of 1968)

of Chapter V of the Act.

A. Please be alerted to the fact that the provisions for penalties for

electronic products under Section 539 of the Act are such that they

cannot be correlated with penalties for devices under Section 303

of the Act.

B. Any references simply to manufacturer that appear in this chapter

include the words assembler and importer, since those words are

included by definition in Section 531(3) [21 U.S.C. 360hh(3)] of the

Act in the word manufacturer.

C. Any references to products in this chapter refer to an electronic

product as that term is defined in Section 531(2) [21 U.S.C.

360hh(2)] of the Act.

6-6-2 Scope

These procedures are provided primarily for guidance in recommending a

civil penalty action; however, instructions for incorporating injunction

recommendations in the civil penalty recommendations are included. See

Section 6-2.

Injunction considerations are included because there is precedent where

the recommended, approved, and executed action was a joint civil penalty

and injunction action. See Exhibit 6-30.

Documents attached as exhibits represent only some of the regulatory

considerations under the Act. These procedures are designed to provide

guidance in recommending an action involving any violation committed

under the Act.
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6-6-3 Legal Authority

Civil penalties are provided for in Section 539 [21 U.S.C. 360pp] of the

Act. Action under this section may be brought in any district court of the

United States in which any act or omission or transaction constituting the

violation occurred, or in any such court where the defendant is found or

transacts business. Process in such cases may be served in any district of

which the defendant is an inhabitant, or wherever the defendant may be

found.

6-6-4 Criteria For Recommending Civil Penalties

The basic criteria for recommending a civil penalty are as follows:

A. A Violation of The Act Has Been Established and Documented.

NOTE: It is not necessary to show a health hazard to initiate action;

such hazards were recognized and implied in the enactment of the

Act by Congress.

1. Section 538(A)(1) [21 U.S.C. 360oo(A)(1)] Introduction or

Delivery for Introduction into Commerce or Importation into The

United States of a Non-Compliant Product

a. This prohibited act only applies to a manufacturer, excluding

diagnostic x-ray assemblers, of an electronic product.

b. A non-compliant product must have been delivered for

introduction or introduced into interstate commerce.

c. Penalty for committing a violation under this section does not

require the manufacturer’s prior knowledge of the

noncompliant state of the product. Nevertheless, a penalties

action is not usually initiated unless a violation has continued

after notice/warning to the defendant.

d. An exception may be made in the case of manufacturers,

where violations are a significant radiation hazard. (If the

defendant(s) continue the violative practice(s) after

notice/warning has been given, the instances of similar

violation occurring prior to the notice/warning then become

subject to inclusion as "counts" in the civil penalty action.

e. Each violation is based on evidence that the product did not

comply with an applicable standard when introduced or

delivered for introduction into commerce by the

manufacturer. Defects, as defined by 21 CFR 1003.2, are

not subject to this charge, unless they constitute noncompliance with a standard.
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2. Section 538(a)(2) [21 U.S.C. 360oo(a)(2)] Failure to Give

Notification or Take Corrective Action

a. The product must be shown to be noncompliant or defective

as a result of its design, production or assembly by the

alleged violative manufacturer. Significant radiation hazards

may be considered for civil penalties without prior

notice/warning. In all other circumstances, the manufacturer

must have been given a reasonable period of time within

which to refute any allegations that the product is

noncompliant or defective.

b. The agency should be in a position to demonstrate that the

manufacturer was aware of the noncompliant or defective

product either through the FDA’s notification or otherwise if

that question is raised.

c. The manufacturer should be given a reasonable period of

time within which to demonstrate that the noncompliant or

defective product does not present a significant risk of injury

to any person and apply for an exemption from notification

and repair under 21 CFR 1003.30 and Section 535(a)(2) of

the Act. An exception may be made in the case of

manufacturers, where violations are a significant radiation

hazard. In these cases, civil penalty without prior

notice/warning will be considered.

d. The agency must be able to demonstrate that at least one of

the following violations has been committed:

i. The manufacturer has not notified the agency of a

defect or noncompliance.

ii. The manufacturer has not notified the known

purchasers of the defect or noncompliance.

iii. The failure of the manufacturer to repair, replace or

refund the cost of noncompliant or defective products.

This may involve either failure to submit a corrective

action plan or failure to implement a plan approved by

the agency.

iv. Charging of purchasers by the manufacturer for the

repair, replacement or refund of a noncompliant or

defective product, including charges for any portion of

an approved corrective action plan.

v. This section applies to dealers and distributors of

electronic products for which there is an applicable

performance standard in that it is a prohibited act for

these individuals to fail to furnish the manufacturer

with such information as may be necessary to identify
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and locate for purposes of Section 535, the first

purchasers of noncompliant products.

3. Section 538(a)(3) [21 U.S.C. 360oo(a)(3)] Failure to Maintain

Records or Permit Inspection

a. The manufacturer must maintain records of the locations of

the first purchasers if the product is subject to the distribution

recordkeeping requirement as specified in Table 1 of 21

CFR 1002.1. The manufacturer must also maintain records

of the locations of any subsequent purchasers which have

been provided to the manufacturer by dealers and

distributors. However, the manufacturer is not responsible

for the location of records of subsequent purchasers which

are not provided to it by dealers and distributors. The agency

may require the manufacturer to request dealers and

distributors to provide this information to it in a corrective

action plan in accordance with 21 CFR 1002.41(a)(1) and

Section 537(f) of the Act.

b. The manufacturer is required to maintain records which

demonstrate the adequacy of its manufacturing practices to

ensure the agency that its safeguards against hazardous

radiation are adequate and that its products comply with an

applicable performance standard.

c. Dealers and distributors of electronic products subject to the

distribution recordkeeping requirement as specified in Table

1 of 21 CFR 1002.1 must maintain records which identify the

product and the location of all first purchasers and make

these records available for inspection or copying by the

agency. Failure to fulfill either of these two requirements

would be considered a violation under this section. Dealers

or distributors are not, however, required to obtain or

maintain this information for subsequent purchasers.

d. The manufacturer and dealer or distributors, after having

been given reasonable notice, are required to make all

required records available for inspection by the agency. The

agency is not required to show cause for this request and

failure to comply by the responsible person or company is a

violation under this section.

e. The agency can require a manufacturer to permit the

inspection of its facilities as well as its required records if

good cause is established.

Grounds for establishing good cause include:

i. introduction of noncompliant or defective electronic

products into commerce by the manufacturer;
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ii. disapproval of the manufacturer’s testing program of

products for which there is an applicable standard; or,

iii. nonsubmission of assurance by the manufacturer in

the form of a report of the adequacy of the product

safeguards against hazardous electronic product

radiation. Failure to permit inspection when good

cause is shown is a violation under this section.

Dealers and distributors, other than those who are also

considered to be manufacturers, are only required to permit

inspection of records described in paragraph iii above.

4. Section 538(a)(4) [21 U.S.C. 360oo(a)(4)] Reporting

a. It is a prohibited act for applicable manufacturers to fail to

provide the agency with product, supplemental, abbreviated,

and annual reports in accordance with 21CFR 1002.10,

1002.11, 1002.12, and 1002.13. Normally regulatory action

should be pursued where the products have an applicable

performance standard or, in the case of flagrant violations,

where no standard has been issued for the product.

b. It is a prohibited act for a manufacturer to fail to provide a

report in conformance with guides or instructions which have

been prescribed under 21 CFR 1002.7(b).

c. It is a prohibited act for any manufacturer of electronic

products to fail to report an accidental radiation occurrence

with its product in accordance with 21 CFR 1002.20.

d. It is a prohibited act for any assembler of diagnostic x-ray

equipment to fail to provide the agency with a report of its

assembly of an x-ray system or component in accordance

with 21 CFR 1020.30(d) (1). This assembler’s report is

required in lieu of the reports cited in paragraph (b)(i) above.

e. It is a prohibited act for dealers or distributors of electronic

products for which there is an applicable performance

standard to fail to report the information required by 21 CFR

1002.40(b) to the manufacturer of the product in accordance

with 21 CFR 1002.41(a)(1) when required for purposes of

Section 535 of the Act and when it has been requested by

either the manufacturer or the Director of the Center for

Devices and Radiological Health (CDRH).

f. It is a prohibited act for a manufacturer or assembler to fail to

report a defect or noncompliance in an electronic product, in

accordance with 21 CFR 1003.20.

g. It is a prohibited act under Section 538 (a)(5)(A) [21 U.S.C.

360oo(a)(5)(A)] for a manufacturer to fail to certify that its

product is in compliance with an applicable performance
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standard. The manufacturer must furnish the certification in

the form of a label or tag, as prescribed by 21 CFR 1010.2.

h. It is a prohibited act under Section 538(a)(5)(B) for any

manufacturer or importer to affix a certification label to a

product which is not in compliance with an applicable

performance standard or for which the testing program has

been disapproved in accordance with Section 534(h) of the

Act. The agency must be able to demonstrate that the

manufacturer would have known, if it exercised due care,

that such certification was materially false or misleading.

B. Prior notice/warning should have been given to the responsible

individuals.

Prior notice may have been by Warning Letter, Notice of

Noncompliance Letter, Program Disapproval Letter, or by any other

method in accordance with Chapter 10 - Other Procedures.

6-6-5 Penalties

A. The Act provides that any person who violates any of the prohibited

acts shall be subject to a civil penalty of not more than $1000 for

each count, with a maximum of $300,000 for any person for any

related series of violations. Where individual responsibility cannot

be proven, civil penalty may be recommended for the firm only.

B. Counts - A count is based upon a violation with respect to each

electronic product involved, or with respect to each act or omission

made unlawful by Section 538. This means that the count is not

determined by the product alone, but by the number of acts

committed in conjunction with each product.

EXAMPLE:

An employee of XYZ Company installs certified components into a

diagnostic x-ray system and fails to file a Report of Assembly (Form

FDA 2579) in accordance with the implementing regulations (21

CFR 1020.30(d)). The prohibited act is Section 538(a)(4) of the Act

for failure to make or provide a report required pursuant to Section

537(b). The required distribution of these reports is to (1) FDA, (2)

the state agency for the installation site, (3) the owner/user of the

system, and (4) either the component manufacturer or XYZ

Company. The distribution of the forms is required within 15 days

from the date of assembly. The responsibility of completing the

forms falls on the individual (employee) who actually performs the

installation and the supervisor or company president who is

responsible for compliance with the standard. In addition, the firm

also has an obligation and responsibility in the filing and

maintenance of required documents.
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Consequently, the following counts in this specific case could be

charged:

Firm Violation of Section 538(a)(4) - 1 count

Employee A Violation of Section 538(a)(4) - 1 count

Manager/President Violation of Section 538(a)(4) - 1 count

Total = 3 counts

This specific example provides for a maximum civil penalty of

$3000 for each occurrence of a failure to file the required report.

The key to determining the number of counts is the "act or omission

made unlawful by Section 538," (i.e., 3 violation instances (counts)

are associated with the 1 product involved in the example cited

above. Each additional product involved with the same violation

would yield 3 additional counts for each occurrence.)

C. The assembler firm could also be charged under the same section

of the Act (Section 538(a)(4)) when the reports continue to be filed

in excess of the 15-day time frame. Reports that are more than 30

days late inhibit FDA’s ability to test newly installed systems for

compliant assembly by the firm. The firm may be attempting to

inhibit compliance testing of their systems. However, for each

violative product, the charge must be either failure to file or filing the

report late. The same installation cannot receive charges under

both categories.

6-6-6 Director Responsibilities

A. The PDD, as appropriate for the action, is responsible for deciding

if the circumstances warrant recommendation of a civil penalty.

Every effort should be made to determine that all necessary

documentation has been obtained, all related samples are included,

and the supporting Establishment Inspection Reports (EIRs) are

complete.

B. The lead coordinator should document as fully as possible who was

responsible for the violations

C. The lead coordinator is responsible for seeing that all violations are

documented.

1. Documentation for each violative product should consist of the

following:

a. Sample Collection Report

b. Complete interstate documentation where Section 538(a)(1)

of the Act is charged.

c. Appropriate affidavits by dealers, purchasers, users, etc.,

where applicable
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d. Copies of appropriate records of proof of sale or installation

of equipment, where applicable.

e. Copies of appropriate labeling.

f. Clear and distinct photographs of labels, and the equipment,

where applicable

g. Copies of all documents that can be considered prior notice

or warning

2. The recommendation packet should consist of the following:

a. Memorandum of recommendation to CDRH explaining the

details of the case. This memorandum should contain the

reasons why you believe that civil penalty is the action of

choice, and should address the size of the business and the

gravity of the violation.

b. A draft letter to the United States (U.S.) Attorney, which

includes the background of the case, a statement of prior

notice/warning, the reasons why we are pursuing this course

of action, and the violations alleged.

c. A Proposed Complaint for Civil Penalty. This complaint

should specify the legal authority for the action

recommended, each specific act committed, or, the manner

in which the act was committed, when and by whom

committed, and the section of the Act violated. The

complaint must reflect the basis of each count for which we

seek a civil penalty. Where possible, use a chart to reflect

instances where more than one count is being charged

under a specific prohibited act. The Complaint should also

include the amount of civil penalty sought, and a brief

description of how it was computed.

d. Copies of appropriate sample records.

e. Copies of EIRs reporting the violation.

f. If an injunction is being sought in the same complaint, an

affidavit, as referenced in the RPM subchapter for

Injunctions, should be prepared and submitted.

D. The lead coordinator shall notify CDRH’s Field Programs Branch

(HFZ-306) that a recommendation is being submitted, and the

recommendation shall be submitted by the most expeditious

means. An electronic copy on a diskette should also be attached to

the recommendation.

E. If the approved letter to the U.S. Attorney and the Complaint for

Civil Penalty are returned to ORA electronically for submission to

the U.S. Attorney, it will be the responsibility of the lead coordinator
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to see that they are delivered to the U.S. Attorney’s office. If the

Complaint includes an injunction, the documents should be

delivered to the U.S. Attorney’s office by the most expeditious and

practical means.

F. The lead coordinator shall be in direct contact with the U.S.

Attorney’s office with regard to timeliness of filing of the complaint,

and scheduling of any hearings, etc.

G. In the event of any hearings in the action, the lead coordinator shall

be responsible for arranging for the presence of any necessary

witnesses, funding, and assuring that all necessary documents are

available.

6-6-7 CDRH Responsibilities

A. CDRH is responsible for a timely review of the recommendation

and for assuring that all the evidence and supporting

documentation are adequate.

If additional information is needed, the lead coordinator will provide

the information, or may, if necessary, make a personal visit to

CDRH.

CDRH will forward a copy of the lead coordinator’s original

recommendation to DE, even though it may prepare an amended

copy to include any deletions or additions of its own.

B. CDRH will prepare a memorandum to DE reflecting the issues

considered by CDRH in reviewing the case and providing the

scientific assurances which support the case.

A copy of CDRH’s concurrence memorandum should be sent to the

recommending ORA unit, at the time that it is forwarded to DE. In

case of disapproval, CDRH shall state clearly the reason for such

disapproval and include any guidance necessary for ORA to

present an acceptable case. If follow-up for additional information is

indicated, CDRH shall be specific as to what is needed, and so

advise ORA. If a case is disapproved, a copy of the disapproval

memorandum shall be sent to DE.

C. CDRH will identify a qualified expert(s) for any court cases.

D. CDRH will provide an affidavit from the CDRH/OC Records

Manager for any notification and reporting charges under Sections

538(a)(2) and (a)(4) of the FD&C Act.

6-6-8 DE Responsibilities

DE will be responsible for ensuring that the recommendation complies

with agency policy. It will review the proposed letter to the U. S. Attorney

and Complaint for Civil Penalty. If it finds that these documents, or any
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other required documents, are not satisfactory, it will be responsible for

obtaining the necessary and proper document(s) and submitting them to

OCC.

DE will be responsible for determining that the necessary distribution is

made of the final documents, as approved by OCC to the appropriate

offices. Approved actions for submission to the U. S. Attorney shall be

forwarded to the ORA lead coordinator by electronic transmission.

6-6-9 OCC Responsibilities

OCC will provide the final legal review of all the documents in the case,

and will determine the legal sufficiency of the evidence. It will be

responsible for any further changes in the Complaint, and/or letter to the

U. S. Attorney, if any. Significant changes will be made in consultation with

DE, CDRH and the lead coordinator, as appropriate. OCC shall designate

an attorney to be responsible for the case. This attorney will provide legal

assistance to the U. S. Attorney’s office and the PDD in the disposition of

the case.

6-6-10Appeals

Appeals of any disapprovals will be handled as prescribed by the Appeal

Process in Chapter 10 of the RPM.

6-6-11Consent Decree of Civil Penalty

The defendant may seek to negotiate a penalty below the maximum for

each count. Such negotiated settlement should be in the form of a

Consent Decree of Civil Penalty. All proposed settlements will be

presented to OCC. All negotiations with the defendant’s lawyers will be

conducted by the lawyer representing the agency, in consultation with DE,

the PDD, and CDRH.

6-6-12Case Termination

Upon notification by the Clerk of the Court that the penalty has been

assessed by the Court and the defendants have paid the penalty, the case

may be closed.

6-6-13Injunction and Civil Penalties

Injunctions under this Act are provided for by Section 539(a) of the FD&C 

Act.

An injunction recommendation should be included with the civil penalty

recommendation if the circumstances warrant it. Criteria to be considered

for injunctive relief include, but are not limited to, the following:
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A. The manufacturer has repeatedly committed the same violation, or

same type of violation.

B. The violative product could cause significant risk of injury to any

person.

C. The manufacturer is continuing to commit the same violations (e.g.,

introduction of noncompliant products into commerce) after being

advised of the agency’s finding and request to cease and desist.

D. The violator refuses to correct previously cited defective or

noncompliant products.

Injunction may be recommended to prohibit certain actions such as the

introduction of violative products into commerce, or to require the violator

to stop violating the Act by taking positive action to correct the existing

violations (e.g. correction of noncompliant or defective products,

notification of purchasers, submission of reports and information, providing

access for inspection, certification of products, etc.).

A recommendation memorandum to CDRH will contain the same

information as the recommendation for a civil penalty, but will include a

statement recommending an injunction, and giving the reasons for the

recommendation.

The letter to the U. S. Attorney and the Complaint will contain the same

background information, but will include the additional request for an

injunction. The subject of the recommendation will address itself to both

the civil penalty and the injunction; and the Complaint will be entitled

"Complaint for Injunction and Civil Penalty."

Whenever the civil penalty recommendation includes an injunction

request, the recommendation will contain the information requested by this

chapter, but will be processed according to the RPM subchapter on

"Injunctions." The counts involved in the action will be the same as

described in this chapter.
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6-7 EXHIBITS

These exhibits include a number of models and examples. They should be used only

as guides and, with the possible exception of legal citations, should not automatically be

used verbatim in any case. Examples from recent cases may be found on ORA's

intranet site. The compliance officer may request examples of inspection warrants, and

other examples not available on ORA's intranet site, from DE,

oraospopenforcementdivio@fda.hhs.gov.

EXHIBIT 6-1

6-1A CMS INSTRUCTIONS (removed)

6-1B CASE INITIATION MEMORANDUM

EXHIBIT 6-2 SEIZURES - U.S MARSHAL LETTER

EXHIBIT 6-3 FORM OF DEFAULT DECREE OF CONDEMNATION

EXHIBIT 6-4 FORM OF CLAIM

EXHIBIT 6-5 FORM OF CONSENT DECREE OF CONDEMNATION

EXHIBIT 6-6 FORM OF BOND

EXHIBIT 6-7 NOTICE TO CLAIMANT

EXHIBIT 6-8 SECOND NOTICE

EXHIBIT 6-9 LETTER TO CANCEL BOND

EXHIBIT 6-10 PROCEDURES & MODELS FOR ISSUING PRESS RELEASES

EXHIBIT 6-11 INJUNCTIONS (MULTI-JURISDICTION)

EXHIBIT 6-12 MODEL LETTER ACKNOWLEDGING COMPLIANCE

EXHIBIT 6-13 DRUG/GMP/ADULTERATION/MISBRANDING CASE –

INTRODUCTORY LANGUAGE FROM A COMPLAINT

EXHIBIT 6-14 FOOD ADULTERATION CASE – INTRODUCTORY LANGUAGE FROM

A COMPLAINT

EXHIBIT 6-15 DRUG GMP CASE – DESCRIPTION OF CHARGE FROM A

COMPLAINT

EXHIBIT 6-16 DIRTY WAREHOUSE CASE – DESCRIPTION OF CHARGES FROM A

COMPLAINT

EXHIBIT 6-17 MISBRANDING (343(A) AND 352(A)) CASE - DESCRIPTION OF

CHARGE FROM A COMPLAINT

EXHIBIT 6-18 EXAMPLES OF CONSENT DECREE PROVISION

EXHIBIT 6-19 EXAMPLES OF COMPLAINT PROVISION
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EXHIBIT 6-20 AFFIDAVIT/DECLARATION

EXHIBIT 6-21 MODEL LETTER BILLING CHARGES

EXHIBIT 6-22 PETITION FOR ORDER TO SHOW CAUSE

EXHIBIT 6-23 ORDER TO SHOW CAUSE

EXHIBIT 6-24 FORMAT FOR PROSECUTION SUMMARY AND RECOMMENDATION

EXHIBIT 6-25 MODEL PROSECUTION SUMMARY AND RECOMMENDATION

MEMORANDUM

EXHIBIT 6-26 MODEL LETTER REQUEST FOR ARTICLES OF INCORPORATION

EXHIBIT 6-27 RULE 44 - PROOF OF OFFICIAL RECORD

EXHIBIT 6-28 RULE 6. THE GRAND JURY

EXHIBIT 6-29 EXAMPLE OF LETTER TO THE DEPARTMENT OF JUSTICE, RE:

INJUNCTION AND CIVIL PENALTY

EXHIBIT 6-30 EXAMPLE OF COMPLAINT FOR INJUNCTION AND CIVIL PENALTY
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Exhibit 6-1

6-1-A: CMS INSTRUCTIONS: See the CMS User Guide on the FDA Intranet
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Exhibit 6-1B: CASE INITIATION MEMORANDUM OUTLINE

A. POINTS OF CONTACT List of Primary Center, Division, Program,

and DE contacts with phone numbers (on the top of the very first

page). Identify any OCC attorneys who have been consulted on the

case.

NOTE THAT THE FORMAT MUST BE AS A NOTE/REFERRAL TO

OCC TO ASSERT THE APPROPRIATE PRIVILEGES TO

PROTECT IT FROM DISCOVERY

B. (Attachment A “LEAD “ASSIGNMENT to CIM ELEMENTS)

1. BRIEF Executive Summary (Description of Evidence): limit to 3

or 4 sentences to identify type of product, conduct and nature of

the case. Just need the big picture, for example: “This is a

proposed permanent injunction against a cheese manufacturer

whose products have been found to be contaminated with

listeria in the past and who has a lengthy history of egregious

sanitation and CGMP deficiencies” OR “This is a proposed mass

seizure of food products stored in a facility infested by rodents.

2. Product Information (Obtain this information from the Center)

a. Examples: Approvals (IND, NDA, 510(k), PMA, IDE,

Licensed, OTC Monograph), if relevant to charges

b. Product Classification or Type e.g., Rx, OTC, Device Class, if

relevant

c. Product Labels and Labeling (hyperlink to Photos and Draft

Complaint)

3. Organizational Chart (hyperlink to EIR and/or Org. Chart)

a. Include a BRIEF description of most responsible person(s)

b. Identify proposed defendants including a hyperlink to evidence

used to support that this is most responsible person (hyperlink

to affidavit and articles of incorporation)

c. Name of current counsel, if known

d. Corporate Relationships (subsidiaries/parent companies)

4. Current Inspection

Rather than a “cut and paste” of the FDA 483 observations, list

the most significant observations/ violations categorized by the

type of violation (e.g., filth, CGMP, labeling violations etc.,) with

reference or hyperlink to details in the EIR AND to the

RELEVANT exhibits (Please do not reference ALL EIR exhibits).
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<INSERT AUTHOR(s) NAME and

DIVISION/PROGRAM/CENTER/DIVISION.

Further Guidance:

a. FDA 483 observation would be explained within the context

of the larger system to frame its significant impact on

production, product safety and public health. Provide critical

insight and context for the observations explaining its impact

on the product or process. For example, rather than “we

observed a hole in the roof of the facility,” explain “we

observed water dripping onto the food being processed from

a hole in the facility’s roof. When including hyperlinks to the

evidence please identify the location of key information

supporting the FDA 483 observation. For example, the

hyperlink to a 42 page laboratory analysis worksheet would

identify the page(s) where key evidence is located.

b. All documented evidence should be in finalized form

(including signatures, as appropriate) whenever possible.

c. If the EIR has not been finalized provide a “separate”

document that captures this information. <INSERT

AUTHOR(s) NAME, DIVISION/PROGRAM/ 

CENTER/DIVISION>

d. FDA 483 Observation Table (Tables of Evidence/Attachment

B). If the firm has offered to correct the violations, explain the

impact on the firm’s/product’s state of compliance, the risk to

public health risk and the regulatory strategy.

<INSERT AUTHOR(s) NAME and

DIVISION/PROGRAM/CENTER/DIVISION>

e. Comparison of Firm’s Repeat Observations (Tables of

Evidence/Attachment B). When possible, include a table with

observations from past inspections to demonstrate recurring

violations (rather than a narrative of each inspection). Insert

hyperlinks in the table or “list of observations” in the report

and the exhibits

<INSERT AUTHOR(s)NAME and DIVISION/PROGRAM/ 

CENTER/DIVISION>

5. Center Office of Compliance Concurrence and Expert 

Information

<INSERT AUTHOR(s) NAME and CENTER/DIVISION>

a. Charges that the Center preliminarily supports (to be later

confirmed through technical/expert support memorandum)
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public health significance of violations<INSERT AUTHOR(s)

NAME and CENTER/DIVISION>

b. Weaknesses- please include Center’s weaknesses in the

combined “ANTICIPATED DEFENSES” (Potential

Weaknesses)* IN THE SECTION BELOW

c. Preliminary Risk Assessment (Counter-arguments to Public

Health significance) (to be confirmed through technical/expert

support memorandum) <INSERT AUTHOR(s) NAME and

CENTER/DIVISION

d. The Center’s review of the Firm’s FDA 483 response. If

incomplete, the status is indicated in Attachment B table,

“Firm’s Stated or Observed Corrective Actions.”

<INSERT AUTHOR(s) NAME and CENTER/`DIVISION.

e. List of most similar precedent cases (Seizure or Injunction or

CMP)

f. The Center’s technical /expert evaluations (e.g., GMP; new

drug) (separate) is needed but if incomplete would not delay

the issuance of the CIM

<INSERT AUTHOR(s) NAME and CENTER/DIVISION

i. Table format (Attachment B) for e.g., GMP violations

is VERY useful; effective and efficient way to compare

current violations with those seen in the past, Focus

on major violations, categories of violations, and link

observations to particular locations and dates. If more

than one, identify the expert (Attachment B) with the

particular charges for which each will testify.

<INSERT AUTHOR(s) NAME and

CENTER/DIVISION>

ii. If in-house experts, provide a CV and direct phone

number and a summary of the expert’s views,

prioritizing the supportable violations in order of

severity and explaining the significance of each

violation.

iii. For outside experts, provide a CV, email address, and

phone number, and confirmation that the expert has

been retained and commitments as to date we can

expect expert’s evaluation if not already completed.

iv. Results of database search if charge involves filing or

registering with FDA or obtaining approval from the

agency or literature search (GRAS/E) when new drug

charges are included.
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<INSERT AUTHOR(s) NAME and

CENTER/DIVISION>

v. HHE if applicable.

<INSERT AUTHOR(s) NAME and

CENTER/DIVISION>

vi. Review by drug shortage staff or evaluated as

medically necessary (device) when appropriate

(Center).

<INSERT AUTHOR(s) NAME and

CENTER/DIVISION>

6. Judicial District

7. Interstate commerce, hyperlink the key single documents (not

an entire CR e.g., doc. Sample/product label) Specify whether

the hyperlinked documents are for finished products or

components (and if components, the names of the associated

finished products);

<INSERT AUTHOR(s) NAME and DIVISION/PROGRAM/ 

CENTER/DIVISION>

8. Complaints-Summary of any consumer complaints and/or

injuries or whistleblower reports

<INSERT AUTHOR(s) NAME and DIVISION/PROGRAM/ 

CENTER/DIVISION>

9. Regulatory History (hyperlink to finalized documents, where

possible and appropriate)

<INSERT AUTHOR(s) NAME and

DIVISION/PROGRAM/CENTER/DIVISION>

a. BRIEF SUMMARY of inspection history including inspection

classification with emphasis on recurring violations (should

be no more than one or two paragraphs) (Cross Reference

TABLES OF EVIDENCE, Attachment B as needed)

b. Recalls (most recent first and should identify products)

c. Warning or Untitled Letters AND response(s) (Cross

Reference TABLES OF EVIDENCE, Attachment B as

needed)

d. Regulatory meeting minutes

e. Written responses from firm (to inspections, 483s, warning or

untitled letters) (Cross Reference TABLES OF EVIDENCE/

Attachment B as needed)
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f. FDA evaluation of firm’s responses (Cross Reference

TABLES OF EVIDENCE/ Attachment B as needed)

g. Other written correspondence from firm or its counsel re: the

violations at issue. Please include a table (Cross Reference

TABLES OF EVIDENCE/ Attachment B as needed)

identifying any correspondence received from the firm

h. Please include a table with the firms corrective actions

(Cross Reference TABLES OF EVIDENCE/Attachment B)

e.g., stated in the firm’s 483 response or other

correspondence or during the re-inspection) as well as

FDA’s evaluation of the correction (whether it was adequate

<INSERT AUTHOR(s) NAME and CENTER/DIVISION>

10.Relief requested (Use drafts from RPM as a starting point and

filed cases as models) although we will rely on OCC to draft the

consent decrees, there are certain substantive provisions which

must be drafted by the centers and ORA divisions or programs,

as they describe the particular technical and scientific steps that

must be taken to bring an operation into compliance. We are

including samples in the RPM Chapter 6 of usual requirements

for a variety of FDA's more typical types of cases. Please note

that these are examples only, not boilerplate, and are intended

to set out the level of detail that the centers and ORA will need

to contribute to the scientific/technical aspects of the relief, in

lieu of preparing a draft consent decree. The assigned center

and ORA personnel must adapt these provisions to the

particular circumstances of each case. In reviewing these

samples, employees are not limited to linking the specific relief to

a particular type of case. For example, in these examples, audit

requirements are set out in the CGMP sections, but there may

be situations in which a food sanitation case will need that type

of relief. Similarly, the examples do not encompass every type of

violation seen in FDA's cases, but they should provide sufficient

guidance to assist in generating the operative portion of the

decree in cases involving other types of violations

<INSERT AUTHOR(s) NAME and DIVISION/ 

PROGRAM/CENTER/DIVISION>

11.Proposed charges and consent decree provisions (Reference

the RPM) Look at all the CDs to pick and choose what will get

them to the goal (take a look at the precedent cases)

12.Anticipated Defenses [Division/Program/ Center/OCC]: Any

potential weaknesses in case including defense’s already known

or advanced by the firm or its counsel. Both ORA and the
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Center need to provide input on potential weaknesses for the

case including any weaknesses that were discussed during the

Preliminary Assessment Call.

<INSERT AUTHOR(s) NAME and DIVISION/

PROGRAM/CENTER/DIVISION>

13.Other reports submitted (or confirmation that none were filed)

such as Field Alert reports, adverse event reports, medical

device reports, post marketing reports.

<INSERT AUTHOR(s) NAME and

DIVISION/PROGRAM/CENTER/DIVISION>
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Exhibit 6-1 Attachment A LEAD ASSIGNMENTS to CIM ELEMENTS

ELEMENT LEAD

A POINTS OF CONTACT List of Primary Center, Division, Program, and

DE contacts with phone numbers (on the top of the very first page).

Identify any OCC attorneys who have been consulted on the case.

1 BRIEF EXECUTIVE SUMMARY (DESCRIPTION OF EVIDENCE)

(limit to 3 or 4 sentences) to identify type of product, conduct and

nature of the case. Just need the big picture, for example: “This is a

proposed permanent injunction against a cheese manufacturer whose

products have been found to be contaminated with listeria in the past

and who has a lengthy history of egregious sanitation and CGMP

deficiencies” OR “This is a proposed mass seizure of food products

stored in a facility infested by rodents .”

2 PRODUCT INFORMATION (Obtain information from the center)

Examples: Approvals [IND, NDA, 510(k), PMA, IDE, Licensed, OTC

Monograph], if relevant to charges

Product Classification or Type e.g., Rx, OTC, Device Class, if relevant

Product Labels and Labeling (hyperlink to Photos and Draft

Complaint)

3 ORGANIZATIONAL CHART (Hyperlink to EIR and/or Org. Chart)

Include a BRIEF description of most responsible person(s)

Identify proposed defendants including a hyperlink to evidence used to

support that this is most responsible person (hyperlink to affidavit and

articles of incorporation)

Name of current counsel, if known

Corporate Relationships (subsidiaries/parent companies)
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ELEMENT LEAD

4 CURRENT INSPECTION

Rather than a “cut and paste” of the FDA 483 observations, list the

most significant observations/violations categorized by the type of

violation (e.g., filth, CGMP, labeling violations etc.,) with reference or

hyperlink to details in the EIR AND to the RELEVANT exhibits (Please

do not reference ALL EIR exhibits).

FURTHER GUIDANCE: FDA 483 observation would be explained

within the context of the larger system to frame its significant impact

on production, product safety and public health. Provide critical insight

and context for the observations explaining its impact on the product

or process. For example, rather than “we observed a hole in the roof

of the facility,” explain “we observed water dripping onto the food

being processed from a hole in the facility’s roof. When including

hyperlinks to the evidence please identify the location of key

information supporting the FDA 483 observation. For example, the

hyperlink to a 42 page laboratory analysis worksheet would identify

the page(s) where key evidence is located

If the EIR has not been finalized provide a “separate” document that

captures this information

FDA 483 Observation Table (Tables of Evidence/Attachment B) if the

firm has offered to correct the violations, explain the impact on the

firm’s/product’s state of compliance, the risk to public health risk and

the regulatory strategy.

Comparison of Firm’s Repeat Observations (Tables of

Evidence/Attachment B). When possible, include a table with

observations from past inspections to demonstrate recurring violations

(rather than a narrative of each inspection). Insert hyperlinks in the

table or “list of observations” in the report and the exhibits

5 CENTER OFFICE OF COMPLIANCE CONCURRENCE AND 

EXPERT INFORMATION

Charges that the Center preliminarily supports (to be later confirmed 

through technical/expert support memorandum) public health 

significance of violations

Please include Center’s weaknesses in the combined 

“CENTER/DIVISION POTENTIAL WEAKNESSES”* section below
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ELEMENT LEAD

Preliminary Risk Assessment (Counter-arguments to Public Health 

Significance) (to be confirmed through technical/expert support 

memorandum)

The Center’s review of the Firm’s FDA 483 response. If incomplete,

the status is indicated in Attachment B (table), “Firm’s Stated or

Observed Corrective Actions.”

List of most similar precedent cases (Seizure or Injunction or Civil 

Money Penalty)

The Center’s technical /expert evaluations (e.g., GMP; new drug) 

(separate) is needed but if incomplete would not delay the issuance of 

the CIM Expert Evaluations (e.g., GMP; new drug, GRAS/E,) –vary

with type of case. If more than one, identify the expert (Attachment B)

with the particular charges for which each will testify.

If in-house experts, provide a CV and direct phone number and a 

summary of the expert’s views, prioritizing the supportable violations 

in order of severity and explaining the significance of each violation

For outside experts, provide a CV, email address, and phone number, 

and confirmation that the expert has been retained and commitments 

as to date we can expect expert’s evaluation if not already completed.

Results of database search if charge involves filing or registering with 

FDA or obtaining approval from the agency or literature search 

(GRAS/E) when new drug charges are included

HHE if applicable

Review by drug shortage staff or evaluated as medically necessary 

(device) when appropriate (Center)

6 JUDICIAL DISTRICT

7 INTERSTATE COMMERCE Hyperlink the key single documents (not

an entire CR e.g., doc. Sample/product label) Specify whether the

hyperlinked documents are for finished products or components (and if

components, the names of the associated finished products)

Finished Product Interstate Documentation

Component Interstate Documentation

8 SHORTAGE REVIEW by drug shortage staff or evaluated as

medically necessary (device) when appropriate
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ELEMENT LEAD

9 COMPLAINTS Summary of any consumer complaints and/or injuries

or whistleblower reports

10 REGULATORY HISTORY (hyperlink to finalized documents, where 

possible and appropriate)

Brief Summary of inspection history including inspection classification 

with emphasis on recurring violations (should be no more than one or 

two paragraphs) (Cross Reference TABLES OF EVIDENCE,

Attachment B as needed)

Recalls (most recent first and should identify products)

Warning or Untitled Letters AND response(s) (Cross Reference

TABLES OF EVIDENCE, Attachment B as needed)

Regulatory meeting minutes

Written responses from firm (to inspections, 483s, warning or untitled 

letters) (Cross Reference TABLES OF EVIDENCE/ Attachment B as 

needed)

FDA evaluation of firm’s responses (Cross Reference TABLES OF 

EVIDENCE/ Attachment B as needed)

Other written correspondence from firm or its counsel re: the violations

at issue. Please include a table (Cross Reference TABLES OF 

EVIDENCE/Attachment B as needed) identifying any correspondence 

received from the firm

Please include a table with the firm’s corrective actions (Cross 

Reference TABLES OF EVIDENCE/Attachment B) e.g., stated in the

firm’s 483 response or other correspondence or during the reinspection) as well as FDA’s evaluation of the correction (whether it 

was adequate

11 RELIEF REQUESTED (Use drafts from RPM as a starting point and

filed cases as models) Specific relief the Center and ORA seeks; e.g.,

stop distribution, initiate a recall, hire consultant. repair facility

Proposed Consent Decree Charges AND consent decree provisions

12 ANTICIPATED DEFENSES [ORA/CENTER/OCC] Any potential

weaknesses in case including defense’s already known or advanced

by the firm or its counsel. Both ORA and the Center need to provide

input on potential weaknesses for the case including any weaknesses

that were discussed during the Preliminary Assessment Call.
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ELEMENT LEAD

13 OTHER REPORTS SUBMITTED (or confirmation that none were

filed) such as Field Alert reports, adverse event reports, medical

device reports, post marketing reports.
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Exhibit 6-1 Attachment B - TABLES OF EVIDENCE

FDA 483 Observation Table (Current Inspection) (Example)

483 Observation Citation Supporting Documents (Hyperlink)

Comparison of Firm’s Repeat Observations (Regulatory History) (Example)

Observation Inspection #1 [DATE] Inspection #2 [DATE] Inspection #3

[DATE]

FDA 483 # [ ] FDA 483 # [ ] FDA 483# [ ]

Center’s Significant FDA 483 Observations and Identified Expert Table

483 Observation 

(Prioritized by

Severity)

Citation Center 

Supported/ Not 

Supported

Expert Identified

(if Center Supported)

Correspondence Received from the Firm (Example)

Correspondence by

Firm or its Agents

ORA Review Center Review Did the FDA

Respond

(Yes or No)

Date FDA 

Responded

[DATE] &

Hyperlink to

Correspondence

[DATE] &

Hyperlink to

review memo

or email

[DATE] &

Hyperlink to

review memo

or email

[DATE] &

Hyperlink 

to FDA 

response

Firm’s Stated or Observed Corrective Actions (Example)

FDA 483 Observation # 

[& Date Observed by 

FDA]

Firm’s Stated 

Correction

ORA Evaluation of the 

Correction

Center Evaluation

of the Correction
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Exhibit 6-2

SEIZURES - U.S MARSHAL LETTER

Reference: SAMPLE NO.

FDC NO.

PRODUCT:

Dear Sir: 

Please refer to Complaint for Forfeiture which has been filed in the above 

referenced matter.

As soon as seizure has been effected, we will appreciate your providing us with 

the following information, which may be furnished by filling in the captions below, 

on the extra copy of this letter enclosed for that purpose.

Sincerely yours,

Enclosure

cc this letter

Self-addressed franked envelope

_______________________________________________________________

DATE SEIZED:

AMOUNT SEIZED:

RETURN DATE (date after which default will be entered):

SEIZED IN POSSESSION OF:

WHERE STORED AFTER SEIZURE:

SEIZED BY: 

__________________________________________________

U.S. Marshal or Deputy Marshal

FORM FDA 487 (6/82)
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Exhibit 6-3

FORM OF DEFAULT DECREE OF CONDEMNATION

IN THE UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF MARYLAND

United States of America, ) No._______________

)

Plaintiff, )

)

v. )

)

So many cartons, more or less, )

of an article of food labeled in part: )

)

"____________________," )

)

Defendant. )

On___________________, 20___, a Complaint for Forfeiture against the above 

described article was filed on behalf of the United States of America. The Complaint 

alleges that the article proceeded against is a food which was adulterated when 

introduced into and while in interstate commerce and is adulterated while held for sale 

after shipment in interstate commerce within the meaning of the Federal Food, Drug, 

and Cosmetic Act, 21 U.S.C. 342(a)(3), in that it consisted in part of a filthy substance 

by reason of the presence therein of insects. Pursuant to warrant for arrest in rem 

issued by this Court, the United States Marshal for this district seized the article 

on__________, 20_____.

It appearing that process was duly issued herein and returned according to law; 

that notice of the seizure of the above described article was given according to law; and 

that no persons have appeared or interposed a claim before the return day named in 

the process;

Now, therefore, on motion of ________________, United States Attorney for the 

District of Maryland, by ___________ _______________, Assistant United States 

Attorney, for a Default Decree of Condemnation and Destruction, the Court being fully 

advised of the premises, it is
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ORDERED, ADJUDGED AND DECREED that the default of all persons be and 

the same are entered herein; and it is further:

ORDERED, ADJUDGED AND DECREED that the seized article is a food (or: 

device, drug, etc.) which was adulterated (or misbranded) when introduced into 

interstate commerce (or: while in interstate commerce, or: is adulterated while held for 

sale after shipment in interstate commerce) within the meaning of 21 U.S.C. 342(a)(3), 

(or appropriate charge) in that it consists in part of a filthy substance by reason of the 

presence therein of insects, (or enter appropriate statement) and is therefore hereby 

condemned and forfeited to the United States pursuant to 21 U.S.C. 334(a); and it is 

further:

ORDERED, ADJUDGED AND DECREED, pursuant to 21 U.S.C. 334(d), that the 

United States Marshal in and for the District of Maryland destroy the condemned article 

and make return to this Court. Destruction shall be in a manner that complies with the 

requirements of the National Environmental Policy Act.

Dated this ____________ day of ___________, 20__.

____________________________

United States District Judge

NOTE:

EXHIBITS: Where exhibits of the seized article are desired for use in displays, to 

illustrate public speeches, or in subsequent prosecution proceedings, the last paragraph

of the above decree should be worded:

(for the entire lot) "*** that the United States Marshal in and for the District of Maryland 

do forthwith deliver same to a representative of the Food and Drug Administration for 

official use or uses***."

(for a portion of the lot) "*** do forthwith deliver a portion of same to a representative of 

the Food and Drug Administration for official use or uses and destroy the remainder of 

same***."
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Exhibit 6-4

FORM OF CLAIM

In the District Court of the United States for the _____________________

District of ________________, ________________ Division. ______________, 

Term, A.D., 20___

UNITED STATES OF AMERICA, )

)

v ) No. ______________, 

___________

) CLAIM

_________________________ )

Now appears before this Honorable Court 

__________________Company, a corporation duly organized and existing under 

the laws of the State of _______________, with its principal place of business in 

the City of __________________, State of ____________________, intervening 

in this proceeding by virtue of its interest as _______________, and prays to 

defend the article(s) above described, and makes claim to the article(s) as the 

same is attached by the United States Marshal for this District under process of 

this Court at the instance of the United States of America, libelant;

And the claimant avers that it has a true and bona fide interest in the 

article; wherefore it prays to defend accordingly.

_____________________ Company

By: __________________________

_____________________________

Proctor for Claimant

State of___________________________)

) SS:
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County of_________________________ )

___________________, being duly sworn, deposes and says that he is the 

_________________ of _________________ Company, the corporation which is 

described in and which executed the foregoing Claim; that he has authority to act 

on behalf of the corporation in this matter and that he signed the Claim pursuant 

to his authority; that he has read the Claim and knows the contents thereof, and 

that the same is true to the best of his knowledge, information, and belief; and 

that he knows the seal affixed to the Claim is the seal of the corporation and was 

duly affixed as such.

_________________________

Sworn to before me this ________________ day of _____________, 20____.

_________________________

Notary Public
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Exhibit 6-5

FORM OF CONSENT DECREE OF CONDEMNATION

In the District Court of the United States for the _______________ District of 

______________________ _______________________Term, A.D., 20____.

UNITED STATES OF AMERICA )

)

v. ) No. ____________, _____________

) Decree of Condemnation

_____________________________ )

On __________________, 20 ___, a Complaint for Forfeiture against the 

above described article was filed in this Court on behalf of the United States of 

America by the Unites States Attorney and the Assistant United States Attorney 

for this District. The Complaint alleges that the article proceeded against is a 

food which was adulterated when introduced into interstate commerce within the 

meaning of the Federal Food, Drug, and Cosmetic Act (Act), 21 U.S.C. 342(a)(3), 

(or appropriate charge) because it consisted of a filthy substance by reason of 

the presence therein of insects. Pursuant to a warrant for arrest in rem issued by 

this Court, the United States Marshal for this District seized the article on _____, 

20__. Thereafter, ____________ Company of _______________, ___________ 

intervened and filed claim to said article. Claimant consents that a decree, as 

prayed for in the Complaint, be entered condemning the article under seizure.

The Court being fully advised of the premises, it is on motion of the 

parties hereto:

ORDERED, ADJUDGED AND DECREED that the seized article is a food 

(or: device, drug, etc.) which was (or is) adulterated (or misbranded) when 

introduced into interstate commerce (or: while in interstate commerce, or: while 

held for sale after shipment in interstate commerce) within the meaning of 21 

U.S.C. 342(a)(3) (or appropriate charge) because it consists in part of a filthy 

substance by reason of the presence therein of insects, (or enter appropriate 

statement) and is therefore hereby condemned and forfeited to the United States 

pursuant to 21 U.S.C. 334(a); and it is further:
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ORDERED, ADJUDGED, AND DECREED, pursuant to 21 U.S.C 334(e), 

that the United States of America shall recover from said Claimant court costs 

and fees, and storage and other proper expenses, as taxed herein, to wit, the 

sum of $______________; and

Claimant having petitioned this Court that the condemned article be 

delivered to it pursuant to 21 U.S.C. 334(d), it is further

ORDERED, ADJUDGED, AND DECREED that the United States Marshal 

for this District shall release said article from his custody to the custody of 

claimant for the purpose of bringing the article into compliance with the Act if 

claimant, within 20 days from the date of this decree, (a) pays in full the 

aforementioned court costs and fees, and storage and other proper expenses of 

this proceeding and (b) executes and files with the clerk of this Court a good and 

sufficient penal bond with surety in the sum of __________ Dollars 

($__________), approved by this Court, payable to the United States of America, 

and conditioned on the claimant's abiding by and performing all the terms and 

conditions of this decree and such further Orders and Decree as may be entered 

in this proceeding; and it is further

ORDERED, ADJUDGED, AND DECREED that:

1. After the filing of the bond in this Court, the claimant shall, at its own 

expense, cause the article to be shipped to its plant at ___________________. 

When the article arrives at the __________________________ plant, claimant 

shall give written notice to the ____________________Division, Division of 

Enforcement, Office of Enforcement and Import Operations, Office of Regulatory 

Affairs, Food and Drug Administration, Department of Health and Human 

Services that the article has arrived and that claimant is prepared to bring it into 

compliance with the law under the supervision of a duly authorized 

representative of the Department of Health and Human Services (DHHS).

2. The claimant shall at all times, until the article has been released by the 

DHHS representative, retain intact the entire lot of goods comprising the article 

for examination or inspection by said representative, and shall maintain the 

records or other proof necessary to establish the identity of said lot to the 

satisfaction of said DHHS representative.
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*3. The claimant shall not commence bringing said article into compliance 

until it has received authorization to do so from the DHHS representative.

NOTE: In mass seizure cases, this item should read as follows:

3. The claimant shall not commence bringing the articles into Compliance 

until the premises have been rendered clean and suitable for the storage of 

______ and it has received authorization to do so from the DHHS representative.

4. The claimant shall at no time, ship, sell, offer for sale, or otherwise 

dispose of any part of the article until the DHHS representative shall have had 

free access thereto in order to take any samples or make any tests or 

examinations that are deemed necessary, and shall in writing have released the 

article for shipment, sale, or disposition.

5. Within 30 days from the date of the filing of the bond in this Court, 

claimant shall complete the process of bringing the article into compliance with 

law under the supervision of the Department of Health and Human Services.

6. The claimant shall abide by the decisions of the DHHS representative 

which decisions shall be final. If claimant breaches any conditions stated in the 

decree, or of any subsequent decree or order of this Court in this proceeding, 

claimant shall return the article immediately to the United States Marshal for this 

District at Claimant's expense, or shall otherwise dispose of it pursuant to an 

order of this Court.

7. The claimant shall not sell or dispose of said article or any part thereof 

in a manner contrary to the provisions of the Federal Food, Drug, and Cosmetic 

Act, or the laws of any State or Territory.

8. The claimant shall compensate the United States of America for cost of 

supervision at the rate of $____________ per hour per person for each day 

actually employed in the supervision of the reconditioning, as salary or wage; 

where laboratory work is necessary, at the rate of $_______ per hour per person 

for such laboratory work; where subsistence expenses are incurred, at the rate of 

$_______ per day per person for such subsistence expenses. Claimant shall 

also compensate the United States of America for necessary traveling expenses 

at $.___ per mile and for any other necessary expenses which may be incurred 

in connection with the supervisory responsibilities of DHHS.
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9. If requested by the DHHS representative claimant shall furnish the 

representative duplicate copies of invoices of sale of the released article, or shall 

furnish such other evidence of disposition as said representative may request.

The United States Attorney for this District, on being advised by the DHHS 

representative that the conditions of this decree have been performed, shall 

transmit such information to the Clerk of this Court, whereupon the bond given in 

this proceeding shall be canceled and discharged; and it is further

ORDERED, ADJUDGED, AND DECREED that if the claimant does not 

avail itself of the opportunity to repossess the condemned article in the manner 

aforesaid, the United States Marshal for this District shall retain custody of said 

article pending the issuance of an order by this Court regarding its disposition; 

and it is further

ORDERED, ADJUDGED, AND DECREED that this Court expressly retains 

jurisdiction to issue further decrees and orders as may be necessary to the 

proper disposition of this proceeding, and should the claimant fail to abide by and 

perform all the terms and conditions of this decree, or of such further order or 

decree as may be entered in this proceeding, or of said bond, then said bond 

shall on motion of the United States of America in this proceeding be forfeited 

and judgment entered thereon.

Dated at ________________, this _________ day of _________, 20____.

___________________________

United States District Judge

We hereby consent to the entry of the foregoing Decree.

______________________________

United States Attorney

______________________________

Assistant United States Attorney

______________________________

Proctor for Claimant
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Exhibit 6-6

FORM OF BOND

In the District Court of the United States for the _______________ District of 

______________, _____________ Division. ____________________Term, 

A.D., 20____

UNITED STATES OF AMERICA, )

)

v. ) No._________, 

_____________.

) Bond

__________________________ )

KNOW ALL MEN BY THESE PRESENTS: That 

_______________________, as Principal, and ____________ ____________, a 

corporation duly organized under the laws of the State of ____________, and 

having a place of business at _____________ ________, as Surety, are held 

and firmly bound unto the United States of America in the sum of 

___________________________ ($_____) Dollars, for the payment of which to 

the United States of America they bind themselves, their representatives, 

successors, and assigns, jointly and severally, firmly by these presents.

WHEREAS, on _________, 20___, a decree was entered in the abovedescribed proceeding, a copy of which Decree is hereto annexed, marked Exhibit 

A, and made a part thereof;

NOW, THEREFORE, the condition of this obligation is such that if the said 

Principal shall abide by and perform all the terms and conditions of said Decree 

and such further Orders and Decrees as may be entered by the abovedesignated Court in this proceeding, then this obligation shall become null and 

void; otherwise it shall remain in full force and effect.

And the Principal and Surety covenant and agree that, by entering into and 

furnishing this Bond, they submit themselves, and each of them, to the 

jurisdiction of the above-designated Court and irrevocably appoint the Clerk of 

Said Court as their agent upon whom any papers affecting their liability on said 
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Bond may be served, that their liability on and under the Bond may be enforced 

on motion made in and to the Court without the necessity of an independent 

action, and that the motion and notice thereof may be served on the Clerk of the 

Court.

Signed with our hands and seals this _____ day of ________, 20___.

______________________________

By: ___________________________

Principal

______________________________

By: ___________________________

Surety

Attest:

____________________________

Secretary

Bond approved _________________, 20__.

UNITED STATES ATTORNEY

__________ Division ______________ District of ___________________, 20__.
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Exhibit 6-7

NOTICE TO CLAIMANT

(Sample No.) June 17, 20__

FDC _____, Civil #_____ U.S. vs. 12 cases ***** and

Shelled Walnuts 9 cases ***** Walnuts

Firm Name

Street Address

City, State, Zip

Dear Sir or Madam:

In accordance with the terms of the decree, these lots of walnuts have been 

satisfactorily reconditioned and the good portion, consisting of 854 lbs., is released for 

your disposition. The rejects, consisting of 30 lbs., have been destroyed under the 

supervision of a representative of this office.

The following supervisory charges were incurred during the reconditioning operations:

Investigator's time 6 hrs. at $**.** per hr $XXX.XX

Mileage-Govt. car 18 miles at $0.*** per mile $ X.XX

Analyst's time 5 hrs. at $**.** per hr $XXX.XX

Total Charges $XXX.XX

(* Note: Use rates of reimbursement specified in Consent Decree)

Please remit promptly a money order, bank draft, or certified check for $XXX.XX, made 

payable to the United States Treasury, attach to the enclosed copy of this letter, and 

forward to:

U.S. Food and Drug Administration

__________ Office

Compliance Branch

Street Address

City, State Zip

Upon receipt of your remittance, we shall advise the United States Attorney that, insofar 

as this office is concerned, the bond posted to cover the decree may be canceled.

Sincerely yours,

____________________________

Director, Compliance Branch Office

Enc: cc this ltr.

cc: Fiscal Branch
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Exhibit 6-8

SECOND NOTICE

(Sample No.) July 17, 20__

FDC _____, Civil #_____ U.S. vs. 12 cases ***** and

Shelled Walnuts 9 cases ***** Walnuts

CERTIFIED MAIL - RETURN RECEIPT

Firm Name

Street Address

City, State, Zip

Dear Sir or Madam:

Under date of June 17, 20__, we mailed you "NOTICE TO CLAIMANT" 

requesting payment for charges incurred in the supervisory operations specified 

in the terms of the decree entered in the above identified seizure action. You 

were requested to remit money order, bank draft, or certified check, in the 

amount of $XXX.XX, to this office. Remittance has not been received.

This is to inform you that unless payment of the costs specified in our letter of 

June 17, 20__, is received within two weeks after the date of receipt of this 

notice, the claim will be referred to the United States Attorney for collection.

Sincerely yours,

_____________________________

Director, Compliance Branch Office

Enc: cc this ltr.

cc: Smith & Smith Attorneys

XYZ Bonding Co.

(Send one month after first Notice; follow up in 2 weeks)
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Exhibit 6-9

LETTER TO CANCEL BOND

(Sample No.) July 25, 20__

FDC _____, Civil #_____ U.S. vs. 12 cases ***** and

Shelled Walnuts 9 cases ***** Walnuts

Honorable _____________

United States Attorney

Street Address

City, State, Zip

Dear ____:

The terms of the Order of Condemnation entered in the above-identified action, 

providing for reconditioning, have been complied with under the supervision of a 

representative of this office.

Costs of supervision have been paid, and insofar as we are concerned the bond 

may be canceled. 

Sincerely yours, 

____________________________

Director, Compliance Branch Office
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Exhibit 6-10

Procedures & Models for Issuing Press Releases

Procedures for Issuing Press Releases on Enforcement Actions

(Seizures & Injunctions)

OCC – Office of Chief Counsel

ORA – Office of Regulatory Affairs

DE – ORA’s Office (Program and District)

OMA – Office of Media Affairs

AUSA – Assistant U.S. Attorney

A. Before Issuing a Press Release

1. Issuance of Press Releases to Publicize Enforcement Actions –

Generally speaking, FDA will issue a Press Release when an 

enforcement action is taken by the Agency. The release should 

include a description of the enforcement action, i.e., type of action, 

basis for action, firm, location, product(s) and firm’s geographical 

market area. In the case of seizure actions, the Letter to the U.S. 

Attorney and Complaint for Forfeiture should be provided by OCC 

to OMA for the drafting of the release. In the case of injunction 

actions, the Complaint for Injunction and/or Consent Decree 

should be provided to OMA by OCC.

2. Decision to Publicize – Typically, the release will be issued at the 

national level. If, however, OMA determines that the release is 

more appropriate for the local level, it will notify OCC (attorney 

assigned to the case), ORA (ORA Headquarters) and the Center 

(Office of Compliance) of its decision.

Example of what would be publicized at local level – firms 

with limited geographic distribution of their products

3. Coordinating with AUSA – The OCC attorney assigned to the case 

contacts the AUSA to inform him/her of FDA’s plans to issue press 

and to obtain concurrence. If the AUSA plans to issue a release, 

FDA typically will defer issuance of the release to the AUSA and 

may request that an FDA quote be included in the DOJ release. 

The OCC attorney notifies OMA whether the AUSA concurs with 

FDA issuing press or prefers to issue one itself.
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4. Drafting and Clearing the Release – If FDA is issuing the release, 

the process for drafting and clearing the `release starts at OMA.

a. OMA creates the first draft of the release using one of the 

attached model press releases (e.g., injunction or seizure). 

OMA routes the release for headquarters review and clearance 

in the following order of offices –

i. Center - Center compliance staff will obtain clearance 

from appropriate Center officials, including the insertion 

of a quote, as appropriate, into the release about the 

action that is being taken.

ii. ORA – ORA Executive Operations Staff will obtain input 

from ORA components by circulating the release to the 

relevant headquarters units and the appropriate ORA 

offices. Program and District input, when provided, will be 

routed through the Division of Enforcement (DE) to 

assure uniformity in enforcement language. Offices will 

be responsible for coordinating review by State officials if 

enforcement action involved our state counterparts. 

When circulating the release for input and comment from 

ORA components, ORA Executive Operations will attach, 

if supplied from OMA, the Final Letter to the U.S. 

Attorney and Complaint for Forfeiture (for seizures) and 

the File Complaint or Consent Decree (for injunctions). 

ORA Executive Operations is responsible for 

coordinating all comments from ORA components. ORA 

Executive Operations will have the responsibility for 

obtaining clearance of the proposed quote from the 

ACRA, ORA Executive Operations staff will obtain final 

ORA document clearance through the ACRA or his/her 

designee and send the final ACRA cleared version 

forward to OMA.

iii. OCC lead case attorney - OCC will give the AUSA a copy 

of the release for review.)

b. After the release is cleared through the three offices listed 

above (Center, ORA, OCC) for technical accuracy, OMA will 

route it through OMA’s standard press release clearance 

process, which involves top agency officials.

5. Final Copy of Press Release – OMA takes comments, makes final 

edits to the release and notifies the above offices, concurrently, as 

appropriate, for last minute edits.

B. Issuance of Press Release

1. Local press release – OMA returns final copy of release to the 

appropriate ORA public affairs specialist (PAS) or compliance 
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officer to format the release on ORA’s letterhead. The PAS issues 

the release to local Associated Press bureau shortly after 

enforcement action has occurred – no later than 24 hours after the 

event. OMA sends copy of release to OMA’s Website 

Management Staff for posting to FDA Website.

2. National press release – OMA will issue and post the release 

using the same procedures as for other agency releases.

3. In the case of seizures, press does not issue until the seizure 

action is completed. If the Complaint for Forfeiture was issued 

under seal, press cannot issue until the seal is lifted. OCC will 

inform OMA of the appropriate time to release the press 

statement.
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Model Press Release – SEIZURE

(FDA Enforcement Actions)

FDA – Recommended Seizure

Carried out by United States Marshals Under Court Order

At the request of the Food and Drug Administration (FDA), the U.S. District Court for the (name 

of district) District of (State) issued a seizure warrant for seizure of (various articles of 

foods/drugs/etc.) at (name of firm) located in (city, state). The U.S. Marshals Office executed 

the seizure warrant (state when).

The seized (name of product(s)) are (adulterated and/or misbranded) under the Federal Food, 

Drug, and Cosmetic Act because (state how the products are adulterated and/or misbranded 

without reference to statute provisions). (Name of firm) distributed the products in (description 

of geographical area where products were distributed) through (types of consignees).

FDA inspections of (name of company) revealed (state what was revealed), for which (name of 

firm) was previously issued a Warning Letter(s) outlining unacceptable practices. The company 

was given an opportunity to correct the violations, but failed to take appropriate action(s).

This product (poses/does not pose) a public health risk because (describe reason why it does 

not pose a risk/OR describe the health risk involved, i.e., contaminated product can cause).

(possible quote by FDA official – OMA will handle)

The FDA advises consumers to (describe whatever action(s) is/are recommended by the agency 

– for example, not to purchase the product, stop using the product, discard the product, return 

to place of purchase, stop using medicine, do not stop using medicine without consulting a 

physician, consult a physician, etc.).

The FDA has initiated this action to promote and protect the public health by enforcing the 

Federal Food, Drug, and Cosmetic Act. FDA’s mission includes ensuring the safety or safety 

and effectiveness of a broad spectrum of regulated products, including food, human and animal 

drugs, vaccines, blood products, medical devices, electronic products that emit radiation, and 

cosmetics.
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Exhibit 6-10 Model Press Release – INJUNCTION

(FDA Enforcement Actions)

Food and Drug Administration Seeks Injunction Against (name/type of firm(s))

The Food and Drug Administration (FDA) is seeking a (permanent/preliminary/

temporary) injunction against (firm’s name and address) to (describe purpose of 

injunction).

The government’s complaint, filed by the U.S. Department of Justice in the U.S. District 

Court for the (name of district) District of (State) charges (name of firm ) with violating 

the Federal Food, Drug, and Cosmetic Act by (describe the charges in plain English). In 

addition to (name of firm), the complaint names as defendants (name and title of 

individual(s)).

The complaint asserts that the defendant(s) has/have carried out (describe the violative 

action(s)) since (the beginning date) despite the FDA’s warning(s) that this/these 

action(s) is/are illegal.

This/these violative action(s) (poses/does not pose) a public health hazard because 

(describe the reason(s) why).

The FDA advises consumers to (describe whatever action(s) is/are recommended by 

the agency – for example, not to purchase the product, stop using the product, discard 

the product, return to place of purchase, stop using medicine, do not stop using 

medicine without consulting a physician, consult a physician, etc.).

The FDA has initiated this action to promote and protect the public health by enforcing 

the Federal Food, Drug, and Cosmetic Act. FDA’s mission includes ensuring the safety 

or safety and effectiveness of a broad spectrum of regulated products, including food, 

human and animal drugs, vaccines, blood products, medical devices, electronic 

products that emit radiation, and cosmetics.
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Exhibit 6-11

INJUNCTIONS (MULTI-JURISDICTION)

INJUNCTIONS

(Multi-jurisdiction)

A. Scope

These procedures apply to injunction actions where the corporate headquarters 

and/or the facilities to be enjoined are located in two or more FDA divisions. The 

procedures describe special coordination requirements for this category of 

injunctions.

These procedures do not supersede the instructions in section 6-2, INJUNCTIONS. 

They are supplementary for only multi-division injunctions involving 2 or more 

facilities in the same corporation. These procedures do not apply to Team 

Biologics.

At its discretion, the recommending division may invoke these procedures for an 

injunction in a single jurisdiction or involving multiple Centers.

B. Objectives

Office of Regulatory Affairs (ORA), Centers and other organizations in FDA are 

involved in the case development activities. A number of case development 

activities must occur concurrently to ensure high quality work products are 

generated with adherence to strict timeframes. These procedures are intended to 

facilitate case processing with respect to:

1. Proactive communication with FDA offices that recommend, review, or concur;

2. Coordination, organization, and scope;

3. Support throughout the case development process;

4. Timelines, milestones, deadlines; and

5. Quality assurance.

C. Responsibilities and Roles

Bringing a timely multi-district injunction of high probative value requires a 

coordinated team effort. To avoid multiple evidence and review updates, redundant 

edits of work products, and miscommunications, the stakeholders should assume 

case ownership and be readily available at all critical stages of case development 

and review.
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1. Program Division Director

The Program Division Director (PDD) will ensure that inspections, investigations, 

and sample collections that support an injunction action are scheduled and 

completed with due diligence. In addition, the PDD will have an active obligation 

to expedite the early alert/notification, establishment inspection report, exhibits, 

collection reports, investigational memos, compliance recommendation, collateral 

assignments, et al. The PDD may delegate these activities as appropriate.

2. Director of Compliance Branch

The Director of Compliance Branch (DCB) will provide administrative oversight 

for case management in the unit. The DCB will ensure continued Division and 

Program responsiveness to case support needs until the case is finally 

adjudicated and follow-up obligations are fulfilled. (S)he has primary 

responsibility to ensure Early Alert/Notification to the Division of Enforcement.

3. Director of Investigations Branch

See “ Early Alert/Notification” section in this exhibit under “Procedure,” below.

4. Director, ORA Division of Enforcement

The Director, Division Enforcement (DE) will provide administrative oversight for 

Compliance Team Coordinator activities. (S)he will ensure continued 

responsiveness to case support needs until the case is adjudicated.

5. Compliance Team Leader

The Compliance Team Leader will typically be the Compliance Officer in the 

recommending unit assigned to the case

The Compliance Team Leader has responsibility for initial review of the evidence, 

drafting a compelling recommendation, and providing overall direction for ORA 

case development activities. In addition, the Compliance Team Leader will:

a. Develop strategy in collaboration with the Compliance Team Coordinator 

and other offices, including the appropriate Center and OCC personnel, 

early in the process, e.g., even at the pre-inspection stage when there is a 

history of noncompliance;

b. Establish deadlines and milestones for meeting timeframes in collaboration 

with the Compliance Team Coordinator;

c. Determine resources, including identification of expertise and division of 

labor, necessary to meet deadlines, milestones, and timeframes;

d. Identify work sharing projects and communicate to the Compliance Team 

Coordinator the need for research, models, assistance in drafting 
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documents or assignments, coordinating conference calls, attending 

meetings, etc. and other needs that will expedite the case and/or 

contribute to quality;

e. Accompany the case to the Center, in appropriate circumstances, unless 

the PDD, Director of DE, or the Center Office of Compliance Director 

conclude that it would serve no useful purpose; and,

f. Provide a copy of the recommendation and all related support documents 

concurrently to the Center and the Compliance Team Coordinator.

6. Compliance Team Coordinator

The Compliance Team Coordinator will typically be a Compliance Officer in DE. 

The Compliance Team Coordinator will act as the ORA headquarters facilitator 

for the case. In addition, the Compliance Team Coordinator will:

a. Collaborate with and provide assistance to the Compliance Team Leader 

to ensure all case development needs are met;

b. Communicate case contact information for each office in the case 

development chain of command (offices that recommend, review, or 

concur);

c. Serve as a liaison to establish open lines of communication within the case 

development and review team at each phase of case evaluation;

d. Facilitate timeliness of work products;

e. Periodically provide a chronology and update of important case events and 

activities to the case development and review chain of command;

f. Identify relevant issues, unexpected events, and other factors impacting 

the case;

g. Conduct a review of the final case recommendation concurrent with the 

Center’s evaluation for the purpose of providing case liaison;

h. Issues identified as part of the Compliance Team Coordinator’s review will 

be deferred to the Compliance Team Leader for resolution.

D. Procedure

Early Alert/Notification: As soon as the PDD, DCB, or Director of Investigations 

Branch (DIB) identifies a potential Multi- jurisdictional injunction, they will provide an 

early alert to the appropriate Center(s) and the Director, Division of Enforcement 

(HFC-200). The early alert should include:

1. The name, address, and FEI numbers of the target corporate office and facilities;

2. Date(s) of the planned, in-process, or completed inspections;

3. General nature of the violations, e.g., GMPs, HACCP, sanitation, etc.; and,

4. Products involved and any special characteristics, e.g., sterile, LACF, medical 
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necessity, etc.

If a Center or other stakeholder has cause to suspect that a multi-district injunction

should be considered, their designee will provide a similar early alert or notification 

to the Director, Division of Enforcement (HFC-200).

The notification can be made by telephone, email, FAX, or other appropriate 

electronic communication. Notifications by telephone should be followed up by a 

written summary that is forwarded to DE (HFC-200) within 2 business days.

The Director, DE will immediately identify a Compliance Team Coordinator and 

communicate that decision to the appropriate Division, Program, and/or Center 

contacts.

E. Organizational Case Management Strategy

Each case presents unique factors and circumstances that if managed properly will 

mitigate delays and evidence development problems.

The Compliance Team Coordinator and the Compliance Team Leader shall jointly 

identify the ORA/Center/OCC stakeholders and initiate a conference call with them 

as soon as practical. The purpose is to front-load the case, facilitate communication 

among the stakeholders, and expedite the case.

The conference call should:

1. Introduce facts and circumstances of the case;

2. Provide an overview of previous regulatory actions, e.g., identify which 

corporations, facilities and products were involved, the types of actions taken, 

and similarities in the violations;

3. Discuss support for the injunction;

4. Identify policy implications, e.g., right case, right area;

5. Discuss case strategy and scope, e.g., all or specific facilities, all or certain 

products; and

6. Identify roles and partnerships, including those of the Program Divisions, the 

Division of Enforcement, programs, and the relevant Center(s).

The stakeholders will typically include offices that recommend, review, or concur; 

and those in positions of Compliance Team Leader; Compliance Team Coordinator; 

DCB; PDDs ; Program Director, Division of Enforcement; Center Office Compliance 

Director, Center Office of Compliance Division Directors, and other Center 

Compliance personnel; Deputy Chief Counsel for Litigation; and appropriate OCC 

Senior Enforcement Advisors(s).
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Exhibit 6-12

MODEL LETTER ACKNOWLEDGING COMPLIANCE

Name

Title

Firm Name

Street Address

City, State, Zip

Re: Injunction

Civil #________

Dear ________:

This is to advise you of the results of an inspection conducted on (Date), at your fish 

processing plant at (Location).

A comparison of the conditions at the plant and your expert's certification statement 

submitted under the terms of the injunction showed that your plant was in compliance 

on that day.

You may, therefore, resume operations at the plant at (Location).

We wish to remind you that the terms of the injunction under which your firm is 

operating require that you maintain your plant in a sanitary condition in the future. Our 

approval of the conditions found on (Inspection Date) should not be construed as 

approval for any conditions that may be found in the future. Should it be determined 

during any future inspection that you have failed to maintain the plant in a proper 

sanitary condition, we will not hesitate to request that the court take whatever steps are 

necessary to ensure compliance.

Very truly yours,

Director
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Exhibit 6-13

DRUG/GMP/ADULTERATION/MISBRANDING CASE – INTRODUCTORY 

LANGUAGE FROM A COMPLAINT

An investigation by the Food and Drug Administration (FDA) of (name of firm, city, 

state) reveals violations of the adulteration and misbranding provisions of the Federal 

Food, Drug, and Cosmetic Act, resulting in various injectable drugs being produced 

contrary to current good manufacturing practices, 21 U.S.C. 351(a)(2)(B); failing to 

have their purported quality because they are not sterile, 21 U.S.C 351(b); and falsely 

stating that they are sterile when they are not, 21 U.S.C. 352(a). We request that 

proceedings be instituted pursuant to 21 U.S.C 332(a) to enjoin (name of firm) and 

(number) of its officers who share responsibility for shipping these adulterated and 

misbranded drugs in interstate commerce in violation of 21 U.S.C. 331(a) and for 

adulterating and misbranding these drugs while holding them for sale after shipment in 

interstate commerce in violation of 21 U.S.C. 331(k). Prior FDA warnings have been 

unsuccessful in promoting the necessary corrections.
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Exhibit 6-14

FOOD ADULTERATION CASE – INTRODUCTORY LANGUAGE FROM A COMPLAINT

An investigation by the Food and Drug Administration (FDA) of (name of firm, city, 

state) reveals violations of the adulteration provisions of the Federal Food, Drug, and 

Cosmetic Act, resulting in human foods becoming adulterated within the meaning of 21 

U.S.C. 342(a)(3) and 342(a)(4), in that they have been manufactured under conditions 

whereby they may have become, and in fact have become, contaminated with filth. We 

request that proceedings be instituted pursuant to 21 U.S.C. 332(a) to enjoin (name of 

firm) and (number) of its officers who share responsibility for adulterating food during 

manufacture in their plant, 21 U.S.C. 331(k), and from shipping adulterated food in 

interstate commerce, 21 U.S.C. 331(a). Prior FDA warnings have been unsuccessful in 

promoting the necessary corrections.
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Exhibit 6-15

DRUG GMP CASE – DESCRIPTION OF CHARGE FROM A COMPLAINT

A drug is deemed to be adulterated within the meaning of the Act, 21 U.S.C. 

351(a)(2)(B), if the methods used in or the facilities or controls used for its manufacture, 

processing, packing, or holding do not conform to or are not operated or administered 

in conformity with current good manufacturing practice. Thus, a drug is adulterated 

regardless of whether it is physically deficient in some respect. The purpose of the 

good manufacturing practice provision of the Act is to control the process of drug 

manufacturing and to attack the production of unreliable drugs in its incipiency, not after 

the fact. United States v. Bel-Mar Laboratories, 284 F. Supp. 875 (E.D.N.Y. 1968); 

United States v. An Article of Drug ... White Quadrisect, 484 F.2d 748 (7th Cir. 1973). 

Injunctive relief incorporating the statutory language of the Act, 21 U.S.C. 351(a)(2)(B), 

has been granted by numerous district courts. See for example the following reported 

cases: United States v. Dianovin Pharmaceuticals, Inc., 342 F. Supp. 724 (D.P.R 

1972), aff'd 475 F.2d 100 (1st Cir. 1973); United States v. Lit Drug Co., 333 F. Supp. 

990 (D.N.J. 1971); United States v. Lanper Co., 293 F. Supp. 147 (N.D. Tex. 1968). 

See also United States v. Medwick Laboratories, 416 F. Supp. 832 (N.D. Ill. 1976). The 

Commissioner of Food and Drugs has published comprehensive regulations specifying 

good manufacturing practice, 21 CFR Part 211. These regulations, referenced in 

paragraph ___ of the Complaint for Injunction, are binding and have the full force and 

effect of law. Abbott Laboratories v. Gardner, 387 U.S. 136 (1967); National Nutritional 

Foods Assoc. v. Weinberger, 512 F.2d 688 (2nd Cir.), cert. denied 423 U.S. 827 

(1975).

(Where applicable add) Because the defendants' manufacturing processes are not 

adequately controlled and are therefore unpredictable, it is not surprising that certain of 

defendants' drugs have become adulterated by being subpotent (or superpotent, or 

both). Samples of defendants' drugs analyzed by the Food and Drug Administration 

establish that such adulteration, within the meaning of 21 U.S.C. 351(b) (or (c)), has in 

fact occurred.
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Exhibit 6-16

DIRTY WAREHOUSE CASE – DESCRIPTION OF CHARGES FROM A COMPLAINT

The injunction charges defendants with violating the Act, 21 U.S.C. 342(a)(3) and 

(a)(4). In order to establish adulteration of food within the meaning of 342(a)(4), proof of 

actual contamination is not required. It is only necessary to prove that the food was 

held under insanitary conditions whereby it may have become contaminated with filth. 

United States v. Wiesenfeld Warehouse Co., 376 U.S. 86 (1964); Berger v. United 

States, 200 F.2d 818 (8th Cir. 1952). The test for determining whether the conditions 

are sufficiently insanitary to cause food to be deemed to be adulterated is whether such 

conditions could, with reasonable possibility, result in contamination. See Berger v. 

United States, supra, at 821; United States v. H.B. Gregory Co., 502 F.2d 700, 704 (7th 

Cir. 1974). However, proof of actual contamination may be used to establish that the 

insanitary conditions could (and did) cause actual contamination. Golden Grain 

Macaroni Co. v. United States, 209 F.2d 166, 167-8 (9th Cir. 1953); Berger v. United 

States, supra, at 823. The words "insanitary conditions" and "filth" have been given 

their usual and ordinary meaning by the Courts; restrictive scientific and medical 

definitions do not apply. United States v. Cassaro, Inc., 443 F.2d 153, 157 (1st Cir. 

1971); United States v. 44 Cases ... Viviano Spaghetti, 101 F. Supp. 658 (E.D. Ill. 

1951).

A violation of 342 (a)(3) requires a showing that a food actually contained filth within the 

meaning of the Act. However, the Government need only prove the presence of filth. 

United States v. 484 Bags ... Coffee Beans, 423 F.2d 839 (5th Cir. 1970); it need not 

establish that the food is unfit, deleterious or dangerous to health. Courts have 

routinely recognized that insect matter and rodent matter is filth within the meaning of 

the Act. The presence of any amount of filth is forbidden by the Act, even filth which is 

capable of being discerned only with the aid of a microscope. United States v. 484 

Bags ... Coffee Beans, supra, at 841; 338 Cartons ... Butter v. United States, 165 F.2d 

728, 730 (4th Cir. 1947).
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Exhibit 6-17

MISBRANDING (343(A) AND 352(A)) CASE - DESCRIPTION OF CHARGE FROM A 

COMPLAINT

Where, as here, labeling is alleged to be false or misleading under 21 U.S.C. 352(a) (or 

343(a)) it is not necessary that the Government prove that all representations are false 

or misleading. Any one false or misleading representation will support a finding that a 

product is misbranded. See United States v. Hoxsey Cancer Clinic, 198 F.2d 273, 281 

(5th Cir. 1952), cert. denied 344 U.S. 928 (1953); United States v. 47 Bottles Jenasol 

RJ Formula 60, 320 F.2d 564, 572 (3rd Cir. 1968), cert. denied 375 U.S. 953; United 

States v. An Article of Device ... Diapulse, 389 F.2d 612 (2nd Cir. 1968), cert. denied 

392 U.S. 907; United States v. One Device ... Colonic Irrigator, 160 F.2d 194, 200 (10th 

Cir. 1947); United States v. 2,000 Plastic Tubular Cases ... Toothbrushes, 352 F.2d 344 

(3rd Cir. 1965), cert. denied 383 U.S. 913 (1966); United States v. An Article of Device 

... Ellis Micro-Dynameter, 224 F. Supp. 265, 268 (E.D. Pa. 1963). A misleading 

statement need not be false to violate the Act; it is enough that a statement has the 

capacity or tendency to deceive, by indirection, ambiguity, or by partial or half-truths. A 

statement can even be technically true in its entirety and still violate the Act. United 

States v. 95 Barrels ... Cider Vinegar, 265 U.S. 438, 442-3 (1924).
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Exhibit 6-18

EXAMPLES OF CONSENT DECREE PROVISIONS

Note: Although we will rely on OCC to draft the consent decrees, there are certain substantive 

provisions which must be drafted by the centers and by ORA offices and programs, as they 

describe the particular technical and scientific steps that must be taken to bring an operation 

into compliance. We are including samples of usual requirements for a variety of FDA's more 

typical types of cases. Please note that these are examples only, not boilerplate, and are 

intended to set out the level of detail that the centers and ORA will need to contribute to the 

scientific/technical aspects of the relief, in lieu of preparing a draft consent decree. The 

assigned center and ORA personnel must adapt these provisions to the particular 

circumstances of each case. In reviewing these samples, employees are not limited to linking 

the specific relief to a particular type of case. For example, in these examples, audit 

requirements are set out in the CGMP sections, but there may be situations in which a food 

sanitation case will need that type of relief. Similarly, the examples do not encompass every 

type of violation seen in FDA's cases, but they should provide sufficient guidance to assist in 

generating the operative portion of the decree in cases involving other types of violations.

FOOD SANITATION (LISTERIA)

I. Upon entry of this Decree, Defendants and each and all of their directors, 

officers, agents, employees, representatives, successors, assigns, attorneys, and any and all 

persons in active concert or participation with any of them each who receive notice of this 

Decree, are permanently restrained and enjoined under the provisions of 21 U.S.C. § 332(a), 

and the equitable authority of this Court, from directly or indirectly receiving, preparing, 

packing, labeling, holding, and distributing at or from their plant located at 

___________________(the “___________facility”), and any other locations at which 

Defendants now or in the future receive, prepare, pack, label, hold, or distribute articles of 

food, any article of food unless and until the following occur:

A. Defendants retain, at their expense, an independent laboratory (the 

“laboratory”) having no personal or financial ties (other than the retention agreement) to 

Defendants or their families, which is qualified to collect product and environmental 

samples from within Defendants’ plant and analyze those samples for the presence of 

Listeria monocytogenes (“L. mono”) in a method that is acceptable to the United States 

Food and Drug Administration (“FDA”). Defendants shall notify FDA in writing 

immediately upon retaining such laboratory and shall provide FDA a copy of the service 

contract. Such service contract shall contain certain provisions, acceptable to FDA, for 

regular environmental and finished product sample collection and analysis, including 

how and where to sample, the number and frequency of samples to be collected, and 

the methods of analysis, in accordance with the Listeria Monitoring Program discussed 

in paragraph ______ below;
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B. Defendants retain, at their expense, an independent expert(s) (the 

“sanitation expert”) having no personal or financial ties (other than the retention 

agreement) to Defendants or their families, and who, by reason of background, 

education, training, and experience, is qualified to inspect Defendants’ plant and to 

determine whether the methods, facilities, and controls are operated and administered 

in conformity with the Act and 21 C.F.R. Part 110. Defendants shall notify FDA in 

writing of the name(s) and qualifications of the sanitation expert(s) as soon as they 

retain such expert(s);

C. Defendants’ sanitation expert, in consultation with the laboratory, 

after review of all FDA observations from ___________to present, develop a written 

Listeria Monitoring Program, acceptable to FDA, which shall include, at a minimum, the 

following:

1. An effective written sanitation control program that establishes 

adequate methods, facilities, and controls for receiving, processing, preparing, 

packing, holding, and distributing articles of food to minimize the risk of 

introduction of L. mono into Defendants’ food, and to ensure that foods are not 

adulterated, within the meaning of 21 U.S.C. § 342(a). Such methods, facilities, 

and controls shall include, but shall not be limited to, thoroughly cleaning, 

sanitizing, renovating, and rendering Defendants’ plant and all equipment therein 

suitable for use in receiving, processing, preparing, packing, holding, and 

distributing articles of food to prevent the articles of food from becoming 

adulterated, and instituting procedures to ensure that the plant and equipment 

therein are continuously maintained in a sanitary condition;

2. A written employee training program (in English and Spanish) that 

includes, at a minimum, instruction on sanitary food handling techniques and 

documentation that each employee has received such training;

3. An effective program of environmental monitoring and testing of the 

plant, conducted by the laboratory, to ensure that Listeria species (L. spp.) are 

controlled, and L. mono is not present, within the plant. Environmental 

monitoring shall include, but not be limited to, collecting swab samples from foodcontact surfaces, equipment, and other environmental sites throughout the facility 

(where the raw ingredients, in-process, and finished articles of foods are 

received, processed, prepared, packed, held, and/or distributed, and common 

areas that could be reservoirs for cross-contamination), and analysis of collected 

samples, in a manner acceptable to FDA. Defendants shall ensure that the 

results of all analyses conducted pursuant to this paragraph are sent to FDA 

within two (2) calendar days of receipt by Defendants;

4. A plan for remedial action should L. spp., L. mono, or any other 

pathogenic organism be detected; and
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5. Assigning continuing responsibility for the operation of the Listeria 

Monitoring Program to a person or persons who, by reason of background, 

experience, or education, is competent to maintain the plant in a sanitary 

condition, coordinate with the laboratory, and implement any necessary remedial 

action(s), and providing such person with the authority to achieve the necessary 

corrections;

6. Defendants make English and Spanish versions of the Listeria 

Monitoring Program available and accessible to all their employees;

D. The sanitation expert conducts a comprehensive inspection of 

Defendants’ plant and the methods and controls used to receive, process, prepare, 

pack, hold, and distribute foods to determine whether Defendants have effectively 

implemented all necessary changes and are operating in compliance with this Decree, 

the Act, and 21 C.F.R. Part 110. The expert shall submit his/her findings to Defendants 

and FDA concurrently, within ten (10) business days of completion of the inspection;

E. Defendants report to FDA in writing the actions they have taken to 

bring their operations into compliance with the Act and all applicable regulations, 

including:

1. Documentation that they have cleaned and sanitized 

their facility and have received laboratory results showing that L. mono is no 

longer present in the facility;

2. Specific measures that they have taken to address 

each of the violations documented by FDA since ___________; and

3. A copy of the Listeria Monitoring Program;

F. Defendants shall destroy, under FDA supervision, all in-process 

and finished articles of food currently in their custody, control, or possession. For 

purposes of this subparagraph, raw ingredients will not be deemed to be in-process if 

they have remained unopened in their original packaging and if Defendants establish to 

FDA’s satisfaction that they have been held under appropriate temperature controls 

since receipt.

G. Defendants recall, to the retail level, all foods distributed since 

___________, at their own expense.

H. FDA, as it deems necessary to evaluate Defendants’ compliance 

with the terms of this Decree, the Act, and all applicable regulations, conducts 

inspections of Defendants’ plant, including the buildings, sanitation-related systems, 

equipment, utensils, all articles of food, and relevant records contained therein;
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I. FDA notifies Defendants in writing that Defendants appear to be in 

compliance with the requirements set forth in subparagraphs ______________ of this 

Decree, the Act, and 21 C.F.R. Part 110;

J. Defendants have paid all costs of inspection, analysis, review, 

investigations, examination, and supervision for FDA’s oversight with respect to 

paragraphs_____________, at the rates set forth in paragraph ______below.

II. Upon resuming operations after completing the requirements of paragraph___, 

Defendants shall continuously implement the following steps to prevent further L. mono

contamination of their food products and facility:

A. Effectively implement, on an ongoing basis, the Listeria Monitoring 

Program developed pursuant to ___________, unless Defendants submit, and FDA 

approves in writing, an alternative L. mono control program, consisting of validated 

methods and controls that are shown to FDA’s satisfaction to eliminate L. mono in food. 

In the event that Defendants, their sanitation expert, or laboratory, determines that the 

Listeria Monitoring Program needs to be revised, Defendants shall provide suggested 

changes to FDA in writing at least twenty (20) days prior to their implementation.

B. Conduct finished product testing in the following manner:

1. Immediately upon resumption of operations after the 

completion of the requirements of paragraph___, Defendants shall test for L. 

mono in all lots of each food product for at least five consecutive production days 

using a testing method acceptable to FDA;

2. After the completion of testing under 

paragraph______, Defendants shall test at least one lot of each food product per 

day for the next twenty (20) production days;

3. After the completion of testing under 

paragraph______, Defendants shall test at least one lot of each food product per 

every five (5) production days for the next three (3) months; and

4. After the completion of testing under paragraph_____, 

Defendants shall test at least one lot of each food product per quarter thereafter.

If any laboratory test completed pursuant to paragraphs _________shows the 

presence of L. mono in any article of food, then Defendants must immediately cease 

production until they have determined and corrected the cause of the microbial 

contamination. Once the cause of the contamination has been corrected, Defendants 

shall reinstate the complete sequence of testing under this paragraph anew

III. If, at any time after entry of this Decree, FDA determines, based on the results of 

an inspection, sample analysis, or other information, that Defendants have failed to comply 
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with any provision of this Decree, have violated the Act or applicable regulations, or that 

additional corrective actions are necessary to achieve compliance with this Decree, the Act or 

applicable regulations, FDA may, as and when it deems necessary, issue a directive notifying 

Defendants in writing of the noncompliance and ordering Defendants to take appropriate 

action, including but not limited to ordering them to take one or more of the following actions 

immediately:

A. Cease receiving, preparing, packing, labeling, holding, or 

distributing articles of food until Defendants receive written notification from FDA that 

they appear to be in compliance with the Decree, the Act, and applicable regulations, 

and that Defendants may resume operations;

B. Recall all articles of food that have been distributed or are under 

the custody and control of Defendants’ agents, customers, or consumers;

C. Submit samples of articles of food to a qualified laboratory to 

determine whether it is contaminated with chemicals, toxins, microorganisms, or filth;

D. Take any other corrective actions as FDA deems necessary to 

protect the public health or bring Defendants into compliance with this Decree, the Act, 

and applicable regulations, including, but not limited to, requiring that Defendants reimplement or re-institute any of the requirements of this Decree.

FOOD SANITATION

I. Upon entry of this Decree, the defendants and each and all of their officers, agents, 

employees, successors, assigns, and attorneys, and any persons in active concert or 

participation with any of them who receive notice of this Decree, are permanently restrained 

and enjoined under the provisions of 21 U.S.C. § 332(a) from directly or indirectly receiving, 

manufacturing, preparing, packing, labeling, and distributing at their plant located at 

_______________________________ (and any new locations at which the defendants 

receive, manufacture, prepare, pack, label, hold, or distribute articles of food), of any soft-shell 

flour tortilla unless and until the following occur:

A. The defendants select an expert or experts (the "sanitation expert") having no 

personal or financial ties (other than a consulting agreement) to the defendants or the 

defendants' manufacturing operations and who, by reason of background, education, 

training, and experience, is qualified to develop, and ensure adequate implementation 

of, a written sanitation control program, covering the defendants' manufacturing 

processes, cleaning and sanitizing operations, pest control, employee health and 

hygiene precautions, and plant construction and maintenance (including the plant's 

buildings and sanitation-related systems (plumbing, sewage disposal), equipment, and 

utensils contained therein), to protect against contamination of food, food-contact 

surfaces, and food-packaging materials with chemicals, toxins, microorganisms, and 

filth, and:
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1. The defendants inform the United States Food and Drug Administration 

(FDA) in writing of the name and qualifications of the sanitation expert(s) as soon 

as they retain such expert;

2. The sanitation expert(s) develops a written sanitation control program 

for preparing, packing, holding, and distributing the defendants' articles of food, 

as described in subparagraph_____;

3. FDA approves, in writing, the sanitation control program developed by 

the sanitation expert(s);

4. The defendants make English and Spanish versions of the sanitation 

control program available and accessible to all their employees;

5. The defendants develop a written employee training program (in 

English and Spanish) that includes, at a minimum, instruction in sanitation control 

requirements for food-handling and manufacturing, and the defendants document 

that each employee has received such training;

6. The defendants assign the responsibility and authority for implementing 

and monitoring the sanitation control program on a continuing basis to an 

employee who is trained in sanitation control requirements;

7. The sanitation expert(s) inspects the defendants' plant, including the 

buildings, sanitation-related systems, equipment, utensils, articles of food, and 

relevant records contained therein, to determine whether the defendants have 

adequately established and implemented the FDA-approved sanitation control 

program, whether the defendants have adequately addressed the FDA 

investigators' inspectional observations listed on each Form FDA-483 issued to 

the defendants since____________, and whether the defendants comply with 

Current Good Manufacturing Practice (CGMP) requirements set forth in 21 

C.F.R. Part 110; and

8. The sanitation expert certifies, in writing, to FDA that the defendants: (i) 

have adequately established and implemented the FDA-approved sanitation 

control program; (ii) have adequately addressed the Form FDA-483 

observations; and (iii) comply with the CGMP requirements in 21 C.F.R. Part 

110.

B. The defendants select an expert (the "food processing expert") having no 

personal or financial ties (other than a consulting agreement) to the defendants or the 

defendants' manufacturing operations and who, by reason of background, education, 

training, and experience, is qualified to develop, and ensure adequate implementation 

of, a food processing quality control program, covering the defendants' processes for 

preparing, packing, and holding soft-shell flour tortillas, to prevent ingredient mix-ups 

and ensure that the soft-shell flour tortillas manufactured by the defendants consistently 
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contain the type and amount of ingredients that they are intended to contain, based on 

pre-established written batch formulations, and:

1. The defendants inform FDA in writing of the name and qualifications of 

the food processing expert as soon as they retain such expert;

2. The food processing expert develops a food processing quality control 

program, as described in subparagraph____, and such food processing quality 

control program, at a minimum, requires: (i) applying and maintaining

identification of raw ingredients in English and Spanish on raw ingredient 

containers; (ii) using appropriate proportions of raw ingredients in the soft-shell 

flour tortillas manufactured by the defendants; (iii) for each size of soft-shell flour 

tortillas manufactured by the defendants, establishing written batch formulations, 

which include the name and amount of the raw ingredients and the complete 

manufacturing instructions; (iv) for each batch of soft-shell flour tortillas 

manufactured by the defendants, preparing a batch production record, which 

documents that each step in the established written batch formulation for the 

product was followed, and lists the lot numbers of each raw ingredient used in 

the batch production; and (v) for each retail and bulk package of soft-shell flour 

tortillas manufactured by the defendants, placing an indelible manufacturing date 

and time code in a conspicuous location on the back panel of the package where 

it is easily readable;

3. FDA approves, in writing, the food processing quality control program 

developed by the food processing expert;

4. The defendants make English and Spanish versions of the food 

processing quality control program – including the established written batch 

formulation for each size of soft-shell flour tortillas manufactured by the 

defendants – available and accessible to all their employees;

5. The defendants develop a written employee training program (in 

English and Spanish) that includes, in addition to the requirements in 

subparagraph_____, instruction in proper food processing techniques and food 

processing quality control, and the defendants document that each employee has 

received such training;

6. The defendants assign the responsibility and authority for implementing 

and monitoring the food processing quality control program on a continuing basis 

to an employee who is trained in food processing quality control requirements;

7. The food processing expert inspects the defendants' plant, equipment, 

utensils, articles of food, and relevant records contained therein, to determine 

whether the defendants have adequately established and implemented the FDAapproved food processing quality control program; and
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8. The food processing expert certifies, in writing, to FDA that the 

defendants have adequately established and implemented the FDA-approved 

food processing quality control program;

C. The defendants, under FDA supervision, examine raw ingredients and inprocess and finished articles of foods at the defendants' plant, and the conditions under 

which they have been stored or held, and the defendants destroy, under FDA 

supervision, all raw ingredients and in-process and finished articles of food as and when 

FDA deems necessary;

D. FDA, as it deems necessary to evaluate the defendants' compliance with the 

terms of paragraph____, conducts inspections of the defendants' plant, including the 

buildings, sanitation-related systems, equipment, utensils, all articles of food, and 

relevant records contained therein;

E. The defendants pay the costs of any supervision, inspection, analyses, 

examination, and review that FDA deems necessary to evaluate the defendants' 

compliance with the terms of paragraph___; and

F. FDA notifies the defendants in writing that the defendants appear to be in 

compliance with the requirements set forth in subparagraphs_____________, 21 C.F.R. 

Part 110, and the Act.

II. Upon resuming operations after completing the requirements of paragraph___, the 

defendants shall notify FDA in writing of any change in the type or amount of raw ingredients in 

any batch formulation for soft-shell flour tortillas (including, but not limited to, switching from an 

ingredient pre-mix to individually packaged ingredients) or any change in manufacturing 

instructions for any soft-shell flour tortilla, at least ten (10) calendar days before implementing 

any such change.

III. The defendants and each and all of their officers, agents, employees, successors, assigns, 

and attorneys, and any persons in active concert or participation with any of them who receive 

notice of this Decree, are permanently restrained and enjoined under the provisions of 21 

U.S.C. § 332(a) from directly or indirectly doing or causing any act that:

A. violates the Act, 21 U.S.C. § 331(a), by introducing, or delivering for 

introduction, into interstate commerce articles of food that are adulterated within the 

meaning of 21 U.S.C. § 342(a)(4);

B. violates the Act, 21 U.S.C. § 331(k), by causing articles of food to 

be adulterated within the meaning of 21 U.S.C. § 342(a)(4) while such articles are held 

for sale after shipment of one or more ingredients in interstate commerce; or

C. failing to implement and continuously maintain the requirements of this 

Decree.
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IV. If, at any time after entry of this Decree, FDA determines, based on the results of an 

inspection, sample analysis, or other information, that the defendants have failed to comply 

with any provision of this Decree, have violated 21 C.F.R. Part 110 or the Act, or that additional 

corrective actions are necessary to achieve compliance with this Decree, 21 C.F.R. Part 110 or 

the Act, FDA may, as and when it deems necessary, issue a directive notifying the defendants 

in writing of the noncompliance and ordering the defendants to take appropriate action, 

including but not limited to ordering the defendants immediately to take one or more of the 

following actions:

A. Cease receiving, manufacturing, preparing, packing, labeling, holding, or 

distributing articles of food until the defendants receive written notification from FDA that 

the defendants appear to be in compliance with the Decree, 21 C.F.R. Part 110, and the 

Act, and that the defendants may resume operations;

B. Recall all articles of food that have been distributed or are under the custody 

and control of the defendants' agents, customers, or consumers;

C. Submit samples of articles of food to a qualified laboratory to determine 

whether the food contains the type and amount of ingredients that it is intended to 

contain and whether it is contaminated with chemicals, toxins, microorganisms, or filth;

D. Take any other corrective actions as FDA deems necessary to protect the 

public health or bring the defendants into compliance with this Decree, 21 C.F.R. Part 

110, and the Act, including but not limited to requiring that the defendants re-implement 

or re-institute any of the requirements of this Decree.

The provisions of this paragraph shall be apart from, and in addition to, all other remedies 

available to FDA. The defendants shall pay all costs of recalls and other corrective actions, 

including the costs of FDA's supervision, inspections, investigations, analyses, examinations, 

and reviews to implement and monitor recalls and other corrective actions, at the rates 

specified in paragraph ______of this Decree.

JUICE HACCP

I. Defendants and each and all of their agents, employees, attorneys, successors, assigns, 

and any persons in active concert or participation with any of them (including individuals, 

directors, corporations, subsidiaries, affiliates, and partnerships) who receive actual notice of 

this Decree, are hereby permanently restrained and enjoined, under the provisions of 21 

U.S.C. § 332(a) and the inherent equitable authority of this Court, from receiving, processing, 

preparing, packing, holding, or distributing juice, at or from Defendants’ juice processing plant 

located at __________________ and at or from any other locations at which Defendants may 

receive, process, prepare, pack, hold, or distribute juice, unless and until:

A. Defendants retain, at Defendants’ expense, an independent person or 

persons (“expert”), who by reason of background, education, training, and experience, 
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is qualified to develop and implement a Hazard Analysis Critical Control Point 

(“HACCP”) plan for juice. The expert shall be without personal or financial ties (other 

than the consulting agreement between the parties) to Defendants or their immediate 

families. Defendants shall notify the United States Food and Drug Administration 

(“FDA”) in writing of the identity of the expert as soon as they retain such expert;

B. The expert develops written HACCP plans for each type of juice processed by 

Defendants, consistent with 21 C.F.R. § 120.8(a) - (c);

C. FDA has approved, in writing, the HACCP plan developed by the expert;

D. Defendants establish and implement to FDA’s satisfaction the written HACCP 

plan, developed by the expert and approved in writing by FDA, that is adequate to 

control food safety hazards likely to occur in the processing of juice, as required by 21 

C.F.R. §§ 120.7 and 120.8;

E. Defendants have the expert validate and certify in writing to FDA that the 

control measures in Defendants’ HACCP plan are adequate to consistently produce, at 

a minimum, a 5-log reduction in the most resistant organism of public health 

significance that is likely to occur in each juice, as required by 21 C.F.R. § 120.24;

F. To the extent Defendants utilize in their production of citrus juice a surface 

treatment process to achieve a 5-log reduction of the most resistant organism of public 

significance, Defendants ensure that their unpasteurized, finished juice products 

containing citrus juice are analyzed for biotype I Escherichia coli (“E. coli”) in 

accordance with the frequency and methods of analysis proscribed in 21 C.F.R. § 

120.25;

G. Defendants, under FDA supervision, according to procedures approved by 

FDA, and as and when directed by FDA, destroy or bring into compliance with the Act 

all food in the plant at the time this Decree is signed;

H. FDA has inspected the plant, including all records relating to the receipt, 

processing, preparation, packing, holding, and distribution of juice; and

I. FDA has notified Defendants, in writing, that the processes and controls used 

for the receipt, processing, preparation, packing, holding, and distribution of juice 

appear to be in compliance with all of the requirements specified in Paragraph ____ of 

this Decree, the Act, and 21 C.F.R. Part 120. And, if such notification is based upon one 

or more FDA inspections, Defendants have paid for such inspection(s) and other work 

at the rates specified in Paragraph ___.

II. Defendants shall immediately provide any information or records to FDA, upon request, 

regarding the receipt, processing, preparation, packing, holding, or distribution of juice. 

Defendants shall maintain a copy of their HACCP plan and all records required by their 

HACCP plan and 21 C.F.R. Part 120 at the plant in a location where they are readily available 
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for reference and inspection by FDA representatives. All records required to be kept by the 

HACCP plan and by regulation shall be retained for at least three (3) years after the date they 

are prepared and shall be presented immediately to FDA investigators upon request.

III. If, at any time after this Decree has been entered, FDA determines, based on the results of 

an inspection, the analyses of samples, a report or data submitted by Defendants or the 

expert, or any other information, that Defendants have failed to comply with any provision of 

this Decree, or have violated the Act or its implementing regulations, or that additional 

corrective actions are necessary to achieve compliance with this Decree, the Act, or its 

implementing regulations, FDA may, as and when it deems necessary, order Defendants in 

writing to immediately cease receiving, processing, preparing, packing, holding, and 

distributing juice, and Defendants shall immediately comply with any such written orders. In 

addition, Defendants shall, as and when FDA deems necessary, recall all articles of food that 

have been distributed or are under the custody and control of Defendants’ agents, distributors, 

customers, or consumers. All costs of such recall(s) and corrective actions shall be borne by 

Defendants. The costs of FDA inspections, sampling, testing, travel time, and subsistence 

expenses to implement the remedies set forth in this paragraph shall be borne by Defendants 

at the rates specified in Paragraph ____.

IV. After Defendants receive written notification from FDA pursuant to Paragraph ____ that 

they appear to be in compliance with Paragraphs ______ of this Decree, Defendants and each 

and all of their agents, employees, attorneys, successors, assigns and any persons in active 

concert or participation with any of them (including individuals, directors, corporations, 

subsidiaries, affiliates, and partnerships) who receive actual notice of this Decree, are 

permanently restrained and enjoined from:

A. directly or indirectly doing or causing any article of food, within the 

meaning of 21 U.S.C. § 321(f), to become adulterated, within the meaning of 21 U.S.C. 

§ 342(a)(4), while such food is held for sale after shipment in interstate commerce; and

B. failing to implement and continuously maintain the requirements of 

this Decree.

SEAFOOD HACCP

I. Defendants and each and all of their officers, agents, employees, successors, 

assigns, attorneys, and those persons in active concert or participation with any of them, are 

perpetually restrained and enjoined under the provisions of 21 U.S.C. § 332(a) from receiving, 

processing, preparing, packing, holding, or distributing, at or from their facility located 

at___________________, and any other locations at or from which defendants process, 

prepare, pack, hold, or distribute food, including any brined, cold-smoked, and hot-smoked fish 

and fishery products, unless and until:
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A. Defendants have thoroughly cleaned and sanitized the facility and equipment 

therein and made improvements, thereby rendering the facility and equipment suitable 

for processing, preparing, packing, holding, and distributing articles of food;

B. Defendants have selected a person or persons (“Listeria expert”), other than

an employee of_____, who by reason of background, experience and education, is 

qualified to develop a raw ingredient testing program, a Sanitation Standard Operation 

Procedure (“SSOP”), an employee training program on sanitary food handling 

techniques and personal hygiene practices, and an environmental microbial monitoring 

program for the genus Listeria (“L. spp.”) for the processing of brined, cold-smoked, and 

hot-smoked fish and fishery products;

C. The Listeria expert has developed a written raw ingredient testing and 

treatment program for Listeria monocytogenes (“L. monocytogenes”), an SSOP, an 

employee training program, and an environmental microbial monitoring program for L. 

spp. for the processing of brined, cold-smoked, and hot-smoked fish and fishery 

products;

D. The United States Food and Drug Administration (“FDA”) has approved in 

writing the raw ingredient testing and treatment program, SSOP, training program, and 

environmental microbial monitoring program developed by the Listeria expert;

E. Defendants, under the supervision of and in accordance with methods 

acceptable to FDA, have examined all lots of brined, cold-smoked, and hot-smoked fish 

and fishery products on hand at the facility for L. monocytogenes, in the following 

manner:

1. Defendants shall select a competent, independent laboratory to 

perform the testing;

2. The name of the laboratory shall be submitted to FDA before the 

testing begins;

3 All written reports of such examinations shall be submitted to FDA 

within two (2) calendar days after receipt by defendants;

4. FDA is authorized to conduct additional analyses and examine the 

articles of food, as it deems necessary, to evaluate whether the articles are 

adulterated; and

5. All brined, cold-smoked, and hot-smoked fish and fishery products 

that contain L. monocytogenes shall be destroyed by defendants under FDA’s 

supervision, or reconditioned under FDA’s supervision pursuant to a 

reconditioning plan approved in writing by FDA prior to its implementation;

F. Defendants have conducted appropriate hazard analyses and have prepared 

Hazard Analysis Critical Control Point (“HACCP”) plans as required by 21 C.F.R. § 
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123.6(b) for all foods, including all brined, cold-smoked, and hot-smoked fish and fishery 

products, received, processed, prepared, packed, held, or distributed at the 

________facility and any other facility, at which defendants conduct their food 

operations. These analyses must be performed, and these plans must be designed to 

the satisfaction of FDA;

G. Defendants develop and implement an ongoing program of adequate 

measures to control L. monocytogenes (“Listeria program”), as described in 

paragraph__.

H. FDA, as it deems necessary to evaluate defendants’ compliance with the 

terms of paragraph____, conducts inspections of the facility;

I. Defendants pay the costs of inspections, supervision, analyses, and 

examination by FDA at the rates specified in paragraph__; and

J. FDA has notified defendants in writing that defendants appear to be in 

compliance with the requirements set forth in paragraphs _____ and with all 

requirements of 21 C.F.R. Parts 110 and 123.

II. Defendants shall have and implement an ongoing program of adequate measures to control 

L. monocytogenes (“Listeria program”). The Listeria program shall include the following 

procedures, unless defendants submit for and receive FDA’s written approval for an alternate 

L. monocytogenes control program, consisting of validated methods and controls, that is 

shown to FDA’s satisfaction to eliminate L. monocytogenes in both the finished product and in 

the facility:

A. Treatment or testing of susceptible raw ingredients. Raw material testing for 

L. monocytogenes shall be performed in accordance with timetables and methods 

submitted to and approved in writing by FDA before testing begins. Defendants shall 

select a competent, independent laboratory to perform the testing. The name of the 

laboratory shall be submitted to FDA before testing begins. Defendants shall ensure 

that the results of all testing conducted pursuant to this paragraph are forwarded to FDA 

within two (2) calendar days after receipt by defendants. Where a sample analysis 

shows the presence of L. monocytogenes in any raw ingredient, the finished product lot 

made in whole or in part from that raw ingredient shall be placed on hold or recalled, as 

FDA deems appropriate, and shall, as FDA deems appropriate, be destroyed by 

defendants under FDA’s supervision, or reconditioned under FDA’s supervision 

pursuant to a reconditioning plan approved by FDA. All expenses of such supervision, 

analyses, and examination by FDA shall be paid by defendants at the rates specified in 

paragraph__;

B. Effective and diligent sanitation procedures for cleaning and sanitizing 

manufacturing equipment and environment to minimize the risk of reintroducing L. 

monocytogenes. These procedures shall consist of the SSOP and the training program 
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developed by the Listeria expert pursuant to the provisions of paragraph ___ and shall 

be implemented on a continuous basis;

C. An effective program for environmental monitoring and testing of 

manufacturing and storage environment to ensure that L. spp. are controlled within the 

facility and L. monocytogenes does not occur in the finished product. The ongoing 

environmental microbial monitoring program shall ensure that the SSOP continues to 

eliminate the L. monocytogenes hazard and that the SSOP is consistently being 

followed. Environmental monitoring shall include collecting swab samples from foodcontact surfaces, equipment, and other environmental sites throughout the facility 

(where the fish or fishery products are received, prepared, packed, and held, up to and 

including final packaging, and common areas that could be reservoirs for crosscontamination), and analyzing such samples for the presence of L. spp. Environmental 

testing for L. spp. shall be performed in accordance with timetables and methods 

submitted to and approved in writing by FDA before testing begins. Defendants shall 

select a competent, independent laboratory to perform the testing and submit the name 

of the laboratory to FDA before testing begins. Defendants shall ensure that the results 

of all testing conducted pursuant to this paragraph are forwarded to FDA within two (2) 

calendar days after receipt by defendants;

D. Additional finished product control measures. Defendants shall implement 

additional control measures to prevent growth of L. monocytogenes in finished products. 

Defendants shall notify FDA regarding the control measures they select. These control 

measures shall continue until, as in the finished product testing described in 

paragraph_____, the laboratory test results show no presence of L. monocytogenes for 

a period of six consecutive months. If, after such six month period, a laboratory test 

result shows the presence of L. monocytogenes, defendants shall reinitiate the 

additional finished product control measures under this paragraph and continue to 

implement them until the laboratory test results show no presence of L. monocytogenes

for a period of six consecutive months; and

E. Finished product testing. To demonstrate compliance with the requirements 

described in ______, finished product testing shall include the following:

1. immediately upon resumption of operations and after completion of 

the requirements in paragraph____, defendants shall test for L. monocytogenes

in each lot of finished product for at least five consecutive production days;

2. immediately after the completion of testing under paragraph_____, 

defendants shall test at least one lot per day for at least the next 20 production 

days;

3. immediately after the completion of testing under paragraph 

______, defendants shall test at least one lot per every five production days for 

the next three months; and
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4. immediately after the completion of testing under 

paragraph______, defendants shall test at least one lot during each three-month

period thereafter.

If any laboratory test listed in subparagraphs _______ show the presence of L. 

monocytogenes in any product, defendants must stop production and, before resuming 

any production, determine and correct the cause of the microbial contamination and 

start the complete sequence of testing again.

III. If, at any time after entry of this Decree, FDA determines, based on the results of an 

inspection, analysis of a sample or samples, or other information, that the defendants have 

failed to comply with any provision of this Decree, have violated the Act or its implementing 

regulations, or that additional corrective actions are necessary to achieve compliance with this 

Decree, the regulations, or the Act, FDA may, as and when it deems necessary, notify the 

defendants in writing of the noncompliance and order the defendants to take appropriate 

action, including, but not limited to, ordering the defendants to immediately take one or more of 

the following actions:

A. Cease receiving, processing, preparing, packing, holding, or distributing any 

article of food;

B. Recall all articles of food that have been distributed or are under the custody 

and control of defendants’ agents, distributors, customers, or consumers; or

C. Take any other corrective actions as FDA deems necessary to bring the 

defendants into compliance with this Decree, FDA regulations, and the Act.

Defendants shall pay all costs of such recalls and corrective actions, including the costs 

of FDA supervision, inspections, analyses, examinations, review, travel, and 

subsistence expenses to implement recalls and other corrective actions, at the rates 

specified in paragraph ___ of this Decree. This provision shall be separate and apart 

from, and in addition to, all other remedies available to FDA.

IV. Any cessation of operations as described in paragraph ___ shall continue until defendants 

receive written notification from FDA that defendants appear to be in compliance with the 

Decree, the Act, and its implementing regulations. After a cessation of operations, and while 

determining whether defendants are in compliance with the Decree, the Act, and its 

regulations, FDA may require that defendants re-institute or re-implement any of the 

requirements of this Decree.

DIETARY SUPPLEMENT

I. Upon entry of this Decree, Defendants and each and all of their directors, 

officers, agents, representatives, employees, attorneys, successors, assigns, and any and all 

persons in active concert or participation with any of them who receive actual notice of this 

Decree by personal service or otherwise, are permanently restrained and enjoined from 
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introducing or delivering for introduction, or causing to be introduced or delivered for 

introduction, into interstate commerce any product unless and until:

A. An approved new drug application or abbreviated new drug 

application filed pursuant to 21 U.S.C. § 355(a) or (j) is effective with respect to the 

product; or

B. An effective investigational new drug exemption filed pursuant to 21 

U.S.C. § 355(i) is in effect for the product; or

C. The product's claims comport with an authorized health claim set 

forth in 21 C.F.R. § 101.72-101.83; or

D. Defendants have received a letter of enforcement discretion for a 

qualified health claim from FDA for that product; or

E. Defendants have removed all claims from Defendants' product 

labels, labeling, promotional materials, websites owned or controlled by or related to 

Defendants, and in any other media that cause that product to be a drug and/or contain 

health claims within the meaning of the Act.

II. Within ten (10) calendar days of FDA's request for any labels, labeling, 

promotional materials, and/or downloaded copies (on CD-Rom) of any internet websites 

owned and controlled by or related to Defendants, Defendants shall submit a copy of the 

requested materials to FDA at the address specified in paragraph___.

III. Within twenty(20) calendar days of entry of this Decree, Defendants shall submit 

to FDA a certification of compliance, signed by each of the individually-named Defendants in 

this matter, each Defendant stating that he: (a) has personally reviewed all of Defendants' 

product labels, labeling, promotional materials, and the internet websites referred to in 

paragraph __ above; and (b) personally certifies that the product labels, labeling, promotional 

materials, and internet websites strictly comply with the requirements of the Act and its 

regulations and do not include claims that the products cure, mitigate, treat, prevent and/or 

reduce the risk of disease. Thereafter, Defendants shall submit certifications of compliance 

every three (3) months for a period of two (2) years.

IV. Within fourteen (14) calendar day of entry of this Decree, Defendants shall retain 

an independent person or persons (the "expert"), without personal, financial (other than the 

consulting agreement between the parties), or familial ties to Defendants or their immediate 

families, who by reason of background, experience, education, and training is qualified to 

assess Defendants' compliance with the Act, to review the claims Defendants make for all of 

their products on their product labels, labeling, promotional material, and any internet websites 

owned or controlled by or related to Defendants including, but not limited to, the websites 

referred to in paragraph ___ above. At the conclusion of the expert's review, the expert shall 

prepare a written report analyzing whether Defendants are operating in compliance with the 

Act and in particular, certify whether Defendants have omitted all claims from their product 
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labels, labeling, promotional materials, websites owned or controlled by or related to 

Defendants and in any other media, that make any of their products drugs and/or constitute 

health claims within the meaning of the Act. The expert shall submit this report to FDA and 

Defendants within thirty-five (35) calendar days of the entry of this Decree. If the expert 

reports any violations of the Act, Defendants shall, within seven (7) calendar days of receipt of 

the report, correct those deviations, unless FDA notifies Defendants that a shorter time period 

is necessary.

V. If, at any time after this Decree has been entered, FDA determines, based on the results of 

an inspection, the analyses of Defendants' product labels, labeling, promotional materials, or 

websites owned or controlled by or related to Defendants, a report prepared by Defendants' 

expert, or any other information, that additional corrective actions are necessary to achieve 

compliance with the Act, applicable regulations, or this Decree, FDA may, as and when it 

deems necessary, direct Defendants, in writing, to take one or more of the actions:

A. Cease manufacturing, processing, packing, labeling, holding, 

and/or distributing any article(s);

B. Submit additional reports or information to FDA;

C. Recall any article(s) at Defendants' expense; or

D. Take any other corrective action(s) as FDA, in its discretion, deems 

necessary to bring Defendants and their products into compliance with the Act, 

applicable regulations, and this Decree.

DRUG CGMP

I. Except as provided in this paragraph, within fifteen (15) calendar days of entry of this 

Decree, Defendants shall, under the United States Food and Drug Administration's ("FDA") 

supervision destroy: (1) all drugs in Defendants' possession, custody, and/or control that are 

the subject of recalls announced by _______________from ___________through_________; 

and (2) in addition to destroying all recalled drugs, all other drugs in Defendant’s possession, 

custody, and/or control, including all in-process drugs and drug components, as well as 

finished drugs. With respect to any additional recalled drugs that subsequently come into 

Defendants’ possession, custody, and/or control, Defendants shall quarantine any such 

products, notify FDA in writing of their receipt, and destroy any such products, under FDA’s 

supervision, no later than thirty (30) calendar days after their receipt. Within thirty (30) 

calendar days of receipt of a reasonable detailed bill of costs, Defendant shall reimburse FDA 

for the supervision of any destruction under this paragraph, at the rates set forth in paragraph 

__ of this Decree. Defendants shall not dispose of any drugs in a manner contrary to any 

federal, state, or local laws, including but not limited to, the National Environmental Policy Act 

of 1969.
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II. Upon entry of this Decree, Defendants and each and all of their subsidiaries, 

directors, officers, agents, representatives, employees, attorneys, successors, and assigns, 

and any and all persons in active concert or participation with any of them who receive actual 

notice of this Decree by personal service or otherwise, are permanently restrained and 

enjoined under 21 U.S.C. § 332(a) from directly or indirectly, doing or causing the 

manufacture, processing, packing, labeling, holding, or distributing, or introducing or delivering 

for introduction into interstate commerce at or from any of the ____facilities, any drug, as 

defined by 21 U.S.C. § 321(g)(1), unless and until:

A. Defendants' methods, facilities, and controls used to manufacture, 

process, pack, label, hold, and distribute drugs are established, operated, and 

administered in conformity with CGMP. 21 U.S.C. § 351(a)(2)(B) and 21 C.F.R. Parts 

210 and 211;

B. Defendants retain, at Defendant's expense, an independent person 

or persons (the "CGMP expert"), who is without any personal or financial (other than the

consulting agreement between the parties), or familial ties to Defendants or their 

immediate families, who by reason of background, training, education, or experience, is 

qualified to inspect Defendants' drug manufacturing facilities to determine whether the 

methods, facilities, and controls are operated and administered in conformity with 

CGMP. Defendants shall notify FDA in writing of the identity and qualifications of the 

CGMP expert as soon as they retain such expert;

C. The CGMP expert shall perform a comprehensive inspection of 

Defendants' facilities and the methods and controls used to manufacture, process, 

package, label, hold, and distribute drugs. The CGMP expert shall determine whether 

Defendants' facilities and the methods and controls used to manufacture, process, 

package, label, hold, and distribute drugs are in compliance with CGMP.

D. The CGMP expert certifies in writing to FDA that:

1. He or she has inspected Defendants' facilities, methods, processes, 

and controls;

2. All CGMP deviations brought to Defendants' attention since 

___________ by FDA, the CGMP expert, or any other source, including but not 

limited to any experts hired prior to the entry of this Decree, have been corrected; 

and

3. Such facilities, methods, processes, and controls are in compliance 

with the requirements of CGMP. As part of this certification, the CGMP expert 

shall include a full and complete detailed report of the results of his or her 

inspection;

E. Defendants report to FDA in writing the actions they have taken to:
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1. Correct the CGMP deviations brought to Defendants' attention by 

FDA, the CGMP expert, and any other source, including but not limited to any 

experts hired prior to the entry of this Decree;

2. Ensure that the methods used in, and the facilities and controls 

used for, manufacturing, processing, packing, labeling, holding, and distributing 

drugs are operated and will be continuously administered in conformity with 

CGMP;

3. Defendants may submit two (2) interim reports under this 

subparagraph, which shall include the CGMP drug expert certification described 

in subparagraph____, in support of the immediate marketing of a priority 

product(s);

F. FDA representatives inspect Defendants' facilities to determine 

whether the requirements of this Decree have been met, and whether Defendants' 

facilities are operating in conformity with CGMP, the Act, and its implementing 

regulations; and

G. FDA notifies Defendants in writing that Defendants appear to be in 

compliance with the requirements set forth in subparagraphs_______. In no 

circumstance will FDA's silence be construed as a substitute for written notification.

III. After Defendants have complied with paragraphs _____ and FDA has notified 

them pursuant to paragraph ___, Defendants shall retain an independent person or persons 

(the "auditor") to conduct audit inspections of ________'s drug manufacturing operations not 

less than once every six (6) months for a period of no less than five (5) years. The auditor 

shall be qualified by education, training, and experience to conduct such inspections, and shall 

be without personal or financial ties (other than a consulting agreement entered into by the 

parties) to any of ________'s officers or employees or their immediate families and may, if 

_____chooses, be the same person or persons described as the CGMP expert and/or 

unapproved new drug expert, as set forth in paragraphs __.

A. At the conclusion of each audit inspection, the auditor shall prepare 

a detailed written audit report ("audit report") analyzing whether Defendants are in 

compliance with the Act, its implementing regulations, and this Decree, and identifying 

in detail any deviations therefrom ("audit report observations"). As a part of every audit 

report, except the first audit report, the auditor shall assess the adequacy of corrective 

actions taken by Defendants to correct all previous audit report observations. The audit 

reports shall be delivered contemporaneously to Defendants and FDA by courier 

service or overnight delivery service, no later than fifteen (15) calendar days after the 

date the audit inspection(s) is completed. If audit reports identify deviations from the 

Act, its implementing regulations, and/or this Decree, FDA may, in its discretion, require 

that the five (5) year auditing cycle be extended or begin anew. In addition, Defendants 
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shall maintain the audit reports in separate files at their facility and shall promptly make 

the audit reports available to FDA upon request.

B. If an audit report contains any adverse observations, Defendants 

shall, within thirty (30) calendar days of receipt of the audit report, correct those 

observations, unless FDA notifies Defendants that a shorter time period is necessary. 

If, after receiving the audit report, Defendants believe that correction of the audit report 

observations will take longer than thirty (30) calendar days, Defendants shall, within ten 

(10) business days of receipt of the audit report, submit to FDA in writing a proposed 

schedule for completing corrections ("correction schedule") and provide justification 

describing why the additional time is necessary. The correction schedule must be 

reviewed and approved by FDA in writing prior to implementation by Defendants. In no 

circumstance will FDA's silence be construed as a substitute for written approval. 

Defendants shall complete all corrections according to the approved correction 

schedule. Within thirty (30) calendar days of Defendants' receipt of an audit report, 

unless FDA notifies Defendants that a shorter time period is necessary, or within the 

time period provided in a correction schedule approved by FDA, the auditor shall review 

the actions taken by Defendants to correct the audit report observations. Within five (5) 

business days of beginning that review, the auditor shall report in writing to FDA 

whether each of the audit report observations has been corrected and, if not, which 

audit report observations remain uncorrected.

New Drug

I. Upon entry of this Decree, Defendants and each and all of their directors, 

officers, agents, employees, representatives, successors, assigns, attorneys, and any and all 

persons or entities in active concert or participation with any of them (including franchisees, 

affiliates, and "doing business as" entities), who have received actual notice of this Decree by 

personal service or otherwise, are permanently restrained and enjoined under 21 U.S.C. § 

332(a), from directly or indirectly doing or causing to be done any of the following acts:

A. Introducing or delivering for introduction into interstate commerce, 

holding for sale after shipment in interstate commerce, manufacturing, processing, 

packing, labeling, holding, or distributing the drugs identified in Appendix A (attached 

hereto) (*Appendix A – list to be supplied by Center) or any drug that is a new drug 

within the meaning of 21 U.S.C. § 321(p), unless and until:

1. an approved new drug application or abbreviated new drug 

application filed pursuant to 21 U.S.C. § 355 is in effect for such drug;

2. an investigational new drug application filed pursuant to 21 U.S.C. 

§ 355(i) and 21 C.F.R. Part 312 is in effect for such drug and the drug is 

distributed and used solely for the purpose of conducting clinical investigations in 

strict accordance with the investigational new drug application; or
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3. Defendants retain, at Defendant's expense, an independent person 

or persons (the "unapproved new drug expert"), without personal, financial (other 

than the consulting agreement between the parties), or familial ties to Defendants 

or their immediate families, who by reason of background, experience, education, 

and training, is qualified to inspect Defendants' facilities, product labeling, 

including promotional material and internet site information, adverse event 

reports, and complaints for all drugs and dietary supplements stored, processed, 

labeled, packed, or distributed by Defendants. Defendants shall notify FDA in 

writing of the identity of the unapproved new drug expert as soon as they retain 

such person.

(a) The unapproved new drug expert shall perform a 

comprehensive inspection of Defendants' facilities, product labeling, 

including promotional material and internet site information, adverse event 

reports, and complaints. The unapproved new drug expert shall 

determine whether Defendants have eliminated drug claims from their 

labeling, including promotional materials and internet information, so the 

products are no longer misbranded or unapproved new drugs;

(b) Defendants' expert shall certify in writing to FDA that 

he or she has inspected Defendants' facilities, product labeling, including 

promotional material and internet site information, adverse event reports 

and complaints, and that Defendants are not making drug claims for their 

products and that such products constitute dietary supplements, within the 

meaning of 21 U.S.C. § 321(ff). As a part of this certification, the 

unapproved new drug expert shall include a full and complete detailed 

report of the results of his or her inspection;

(c) Defendants shall report to FDA in writing the actions 

they have taken to eliminate drug claims from their labeling, including any 

promotional materials and internet site information. Defendants may 

submit two (2) interim reports under this subparagraph, which shall include 

the unapproved new drug expert certification described in 

subparagraph_____, in support of the immediate marketing of a priority 

product(s);

(d) Within forty-five (45) calendar days after receiving a report 

under subparagraph____, FDA shall either notify Defendants in writing 

that, with respect to the products identified in the report as being reviewed, 

(1) they appear to be compliance with the requirement of this Decree and 

the Act, or (2) they do not appear to be in compliance with the 

requirements of this Decree and the Act, along with the reasons for such 

appearance of noncompliance.
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B. Introducing or delivering for introduction into interstate commerce any drug 

that is adulterated within the meaning of 21 U.S.C. § 351(a)(2)(B);

C. Causing the adulteration of any drug within the meaning of 21 U.S.C. § 

351(a)(2)(B), while such drug is held for sale after shipment of one or more components 

in interstate commerce; and

D. Introducing or delivering for introduction into interstate commerce any drug 

that is misbranded within the meaning of 21 U.S.C. § 353(b)(4)(B).

II. After Defendants have complied with paragraphs _____ and FDA has notified 

them pursuant to paragraph ___, Defendants shall retain an independent person or persons 

(the "auditor") to conduct audit inspections of __'s drug manufacturing operations not less than 

once every six (6) months for a period of no less than five (5) years. The auditor shall be 

qualified by education, training, and experience to conduct such inspections, and shall be 

without personal or financial ties (other than a consulting agreement entered into by the 

parties) to any of __'s officers or employees or their immediate families and may, if 

_____chooses, be the same person or persons described as the CGMP expert and/or 

unapproved new drug expert, as set forth in paragraphs __.

A. At the conclusion of each audit inspection, the auditor shall prepare 

a detailed written audit report ("audit report") analyzing whether Defendants are in 

compliance with the Act, its implementing regulations, and this Decree, and identifying 

in detail any deviations therefrom ("audit report observations"). As a part of every audit 

report, except the first audit report, the auditor shall assess the adequacy of corrective 

actions taken by Defendants to correct all previous audit report observations. The audit 

reports shall be delivered contemporaneously to Defendants and FDA by courier 

service or overnight delivery service, no later than fifteen (15) calendar days after the 

date the audit inspection(s) is completed. If audit reports identify deviations from the 

Act, its implementing regulations, and/or this Decree, FDA may, in its discretion, require 

that the five (5) year auditing cycle be extended or begin anew. In addition, Defendants 

shall maintain the audit reports in separate files at their facility and shall promptly make 

the audit reports available to FDA upon request.

B. If an audit report contains any adverse observations, Defendants 

shall, within thirty (30) calendar days of receipt of the audit report, correct those 

observations, unless FDA notifies Defendants that a shorter time period is necessary. 

If, after receiving the audit report, Defendants believe that correction of the audit report 

observations will take longer than thirty (30) calendar days, Defendants shall, within ten 

(10) business days of receipt of the audit report, submit to FDA in writing a proposed 

schedule for completing corrections ("correction schedule") and provide justification 

describing why the additional time is necessary. The correction schedule must be 

reviewed and approved by FDA in writing prior to implementation by Defendants. In no 

circumstance will FDA's silence be construed as a substitute for written approval. 

Defendants shall complete all corrections according to the approved correction 
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schedule. Within thirty (30) calendar days of Defendants' receipt of an audit report, 

unless FDA notifies Defendants that a shorter time period is necessary, or within the 

time period provided in a correction schedule approved by FDA, the auditor shall review 

the actions taken by Defendants to correct the audit report observations. Within five (5) 

business days of beginning that review, the auditor shall report in writing to FDA 

whether each of the audit report observations has been corrected and, if not, which 

audit report observations remain uncorrected.

NEW DRUG/MONOGRAPH

I. Before Defendants may commence manufacturing or distributing any new drug product or 

continue the manufacture or distribution of any previously distributed drug that is a new drug 

within the meaning of 21 U.S.C. § 321(p), Defendants shall first notify FDA in writing of their 

intention to do so, and shall also do the following:

A. For any drug that is an OTC drug and is not manufactured and labeled in 

strict conformance with an applicable OTC monograph under the terms of 

subparagraph______, Defendants shall demonstrate to FDA that the drug is the subject 

of either (1) an approved application filed under 21 U.S.C. § 355(a) or § 355(j), or (2) an 

effective investigational new drug application filed under 21 U.S.C. § 355(i). In no event 

may Defendants distribute a drug product that is not the subject of an approved 

application under 21 U.S.C. §§ 355(a) or (j), or the subject of an effective investigational 

new drug application under 21 U.S.C. § 355(i), which must explicitly authorize 

manufacture of the drug at Defendants’ facility;

B. If the product purports to be an OTC monograph drug as described in 

paragraph ______, Defendants may not distribute such drug unless and until:

1. Defendants retain, at Defendants’ expense, an independent person 

or persons (the “drug monograph expert”), who is without any personal or 

financial ties (other than the agreement) to Defendants and their families, and 

who, by reason of background, training, education, or experience, is qualified to 

review the labeling of Defendants’ OTC drug(s) to determine whether such 

product complies with the applicable OTC drug monograph and other labeling 

requirements of the Act and FDA regulations. Defendants shall notify FDA in 

writing of the identity and qualifications of the drug monograph expert as soon as 

they obtain such expert;

2. The drug monograph expert performs a comprehensive review of 

the OTC drug and the drug’s proposed labeling to determine whether the product 

strictly conforms to an applicable FDA OTC monograph and all labeling 

requirements, including 21 C.F.R. Part 201, and that the OTC drug is not 

otherwise misbranded;
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3. The drug monograph expert certifies in writing to FDA that: (a) he 

or she has reviewed the OTC drug and its labeling; (b) the OTC drug and its 

labeling conform to the requirements of an OTC drug monograph and all 

applicable labeling requirements, including 21 C.F.R. Part 201; and (c) the OTC 

drug is not otherwise adulterated or misbranded. As part of this certification, the 

drug monograph expert shall attach the labeling he or she has received to a full 

and complete detailed report of the results of his or her review, including, but not 

limited to, identifying the labeling he or she reviewed and references to the OTC 

monograph and labeling regulations addressed in the process of conducting the 

labeling review;

4. Defendants have provided to FDA any additional information 

requested by FDA after FDA’s review of the drug monograph expert’s 

certification pursuant to subparagraph ________; and

5. FDA notifies Defendants in writing that Defendants appear to be in 

compliance with the requirements set forth in subparagraphs_________, the Act, 

and the applicable regulations related to OTC drug products. In no circumstance 

may FDA’s silence be construed as a substitute for written notification. If FDA 

finds, after issuance of this notification, that Defendants are not in compliance 

with subparagraphs __________, the Act, or applicable regulations related to 

OTC drug products, Defendants, upon notification from FDA, shall immediately 

take whatever action that FDA specifies.

II. If, at any time after this Decree has been entered, FDA determines, based on the 

results of an inspection, the analyses of samples, a report or data prepared or 

submitted by defendants, the expert, the auditor, or any other information, that 

defendants have failed to comply with any provision of this Decree, or have 

violated the Act, its implementing regulations, or that additional corrective actions 

are necessary to achieve compliance with this Decree or the Act, FDA may, as 

and when it deems necessary, order defendants in writing to take appropriate 

action, including, but not limited to, one or more of the following actions:

A. Cease manufacturing, processing, packing, labeling, holding, and 

distributing any or all drug(s);

B. Revise, modify, or expand any report(s) or plan(s) prepared 

pursuant to this Decree;

C. Submit additional reports or information to FDA;

D. Recall specified drug products released or distributed by 

defendants or that are under the custody and control of defendants' agents, distributors, 

customers, or consumers. Defendants shall bear the costs of such recall(s); and/or
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E. Take any other corrective action(s) as FDA, in its discretion, deems 

necessary to protect the public health or bring defendants into compliance with the Act, 

its implementing regulations or this Decree.

DEVICE APPROVAL/CLASSIFICATION/CGMP

I. Upon entry of this Decree, Defendants, and each and all of their directors, 

officers, agents, representatives, employees, attorneys, successors, and assigns, and any and 

all persons in active concert or participation with any of them (including franchisees, affiliates, 

and "doing business as" entities), who have received actual notice of the contents of this 

Decree by personal service or otherwise, are permanently restrained and enjoined, pursuant to 

21 U.S.C. § 332(a), from directly or indirectly designing, manufacturing, processing, packing, 

repacking, labeling, holding, distributing, importing into or exporting from the United States of 

America, any device, unless and until:

A. Defendants' methods, facilities, and controls used to manufacture, 

process, pack, label, hold, and distribute devices are established, operated, and 

administered in compliance with 21 U.S.C. § 360j(f)(1) and the Quality System 

regulation prescribed in 21 C.F.R. Part 820.

B. Defendants select and retain at their expense an independent 

person or persons (the "Expert"), to conduct inspections of Defendants' operations and 

to review Defendants' procedures and methods for designing, manufacturing, 

processing, packing, repacking, labeling, holding, and distributing devices, to determine 

whether their methods, facilities, and controls are operated and administered in 

conformity with the Act, its implementing regulations, and this Decree. The Expert shall 

be qualified by education, training, and experience to conduct such inspections, and 

shall be without personal or financial ties (other than a consulting agreement between 

the parties) to Defendants’ officers or employees or their immediate families. 

Defendants shall notify FDA in writing of the identity of the Expert within ten (10) 

calendar days of retaining such Expert.

C. The Expert shall perform a comprehensive inspection of 

Defendants' operations and certify in writing to FDA: (1) that he or she has inspected 

Defendants' facilities, processes, and controls; (2) whether Defendants have corrected 

all violations set forth in FDA's Inspectional Observations (Forms FDA 483) from all prior 

FDA inspections since ___________; and (3) based upon this comprehensive 

inspection, whether Defendants' operations are operated in conformity with the Act, its 

implementing regulations, and this Decree. The Expert's certification report shall 

encompass, but not be limited to, an evaluation of the following:

1. Defendants' compliance with 21 U.S.C. §§ 351(h), 360j(f)(1), 

352(t)(2), and 352(o), and 21 C.F.R. Parts 803 and 820;
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2. Defendants' procedures for its Corrective and Preventive Action 

("CAPA") system including, but not limited to: analyzing quality data to identify 

existing and potential causes of nonconforming product and other quality 

problems; investigating the causes of nonconformities relating to product, 

processes, and the quality system; identifying the action(s) needed to correct and 

prevent recurrence of nonconforming product and other quality problems; 

verifying or validating corrective and preventative actions to ensure such actions 

are effective and do not adversely affect the finished device; implementing and 

recording changes in methods and procedures as needed to correct and prevent 

quality problems; conducting and documenting adequate failure investigations; 

and implementing an effective complaint handling system;

3. Defendants' design control system, including the design change 

control process; and

4. Defendants procedures to adequately control received or 

purchased products to verify conformance to product specifications.

D. Defendants report to FDA in writing the actions that they have 

taken to: (1) correct all violations brought to Defendants' attention by the Expert and/or 

set forth in FDA's Inspectional Observations from all prior FDA inspections 

since______; and (2) ensure that the methods used in, and the facilities and controls 

used for designing, manufacturing, processing, packing, repacking, labeling, holding, 

and distributing devices are operated and administered and will be continuously 

operated and administered in conformity with the Act, its implementing regulations, and 

this Decree.

E. FDA representatives inspect Defendants' operations to determine 

whether the requirements of this Decree have been met, and whether Defendants' 

operations are otherwise operated in conformity with current good manufacturing 

practice, the Act, and its implementing regulations.

F. FDA notifies Defendants in writing that Defendants appear to be in 

compliance with the requirements set forth in paragraphs _________ of this Decree.

II. Before Defendants may commence designing, manufacturing, or distributing any device, 

they shall first notify FDA in writing of their intent to do so, and shall demonstrate to FDA that 

the device is either (a) the subject an approved application for premarket approval pursuant to 

21 U.S.C. § 360e(a); (b) the subject of a cleared premarket notification pursuant to 21 U.S.C. § 

360(k); or (c) is exempt from the premarket approval/clearance requirements. Defendants 

shall not commence distributing any device prior to receiving written notification from FDA that 

the device appears to be in compliance with this paragraph. In no circumstances may FDA's 

silence be construed as a substitute for written notification.
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III. After Defendants have complied with paragraphs ______ and FDA has notified 

Defendants in writing pursuant to paragraph_______, Defendants shall retain an independent 

person or persons (the "Auditor") at Defendants' expense to conduct audit inspections of 

Defendants' operations not less than once every six (6) months for a period of one (1) year and 

not less than once every twelve (12) months for a period of four (4) years thereafter, for a total 

of five (5) years. The Auditor shall be qualified by education, training, and experience to 

conduct such inspections, and shall be without personal or financial ties (other than a 

consulting agreement entered into by the parties) to Defendants' officers or employees or their 

immediate families. The Auditor may be the same person or persons described as the Expert 

in paragraph____.

A. At the conclusion of each audit inspection, the Auditor shall prepare 

a written audit report (the "Audit Report") analyzing whether Defendants' operations are 

conducted and administered in compliance with the Act, its implementing regulations, 

and this Decree, and identifying in detail any deviations from the foregoing ("Audit 

Report Observations"). As part of every Audit Report, except the first, the Auditor shall 

assess the adequacy of corrective actions taken by Defendants to correct all previous 

Audit Report Observations. The Audit Reports shall be delivered contemporaneously to 

Defendants and FDA by courier service or overnight delivery service, no later than 

twenty (20) calendar days after the date the audit inspections are completed. If any 

Audit Reports identify any deviations from the Act, its implementing regulations, and/or 

this Decree, FDA may, in its discretion, require that the five (5) year auditing cycle be 

extended or begin anew. In addition, Defendants shall maintain complete Audit Reports 

and all of their underlying data in separate files at their facilities and shall promptly make 

the Audit Reports and underlying data available to FDA upon request.

B. If an Audit Report contains any adverse Audit Report Observations, 

Defendants shall, within thirty (30) calendar days of receipt of the Audit Report, correct 

those observations, unless FDA notifies Defendants that a shorter time period is 

necessary. If, after receiving the Audit Report, Defendants believe that correction of 

any adverse Audit Report Observation will take longer than thirty (30) calendar days, 

Defendants shall, within ten (10) calendar days of receipt of the Audit Report, propose a 

schedule for completing corrections ("Correction Schedule") and provide justification for 

the additional time. That Correction Schedule must be reviewed and approved by FDA 

in writing prior to implementation. Defendants shall complete all corrections according 

to the approved Correction Schedule. Within thirty (30) calendar days of Defendants' 

receipt of an Audit Report, or within the time period provided in a Correction Schedule 

approved by FDA, the Auditor shall review the actions taken by Defendants to correct 

the adverse Audit Report Observation(s). Within five (5) calendar days of the beginning 

of that review, the Auditor shall report in writing to FDA whether each of the adverse 

Audit Report Observations has been corrected and, if not, which adverse Audit Report 

Observations remain uncorrected.
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IV. If, at any time after this Decree has been entered, FDA determines, based on the 

results of an inspection, the analysis of samples, a report or data prepared or submitted by 

Defendants, the Expert, or the Auditor pursuant to this Decree, or any other information, that 

Defendants have failed to comply with any provision of this Decree, or have violated the Act or 

its implementing regulations, or that additional corrective actions are necessary to achieve 

compliance with this Decree, the Act, or its implementing regulations, FDA may, as and when it 

deems necessary, order Defendants in writing to take appropriate actions. Such actions may 

include, but are not limited to, the following:

A. Cease designing, manufacturing, processing, packing, repacking, 

labeling, holding, storing, distributing, installing, servicing, importing, and/or exporting 

devices;

B. Revise, modify, or expand any report(s) prepared pursuant to the 

Decree;

C. Submit additional notifications, reports, or any other materials or 

information to FDA;

D. Recall, at Defendants' sole expense, adulterated or misbranded 

devices or components therein manufactured, distributed, and/or sold by Defendants or 

that are under the custody and control of Defendants' agents, distributors, customers, or 

consumers;

E. Issue a safety alert, public health advisory and/or press release; 

and/or

F. Take any other corrective action(s) as FDA, in its discretion, deems 

necessary to protect the public health or to bring Defendants into compliance with Act, 

its implementing regulations, and this Decree.

NO PMA/NO 510K

I. Defendants and each of their directors, officers, agents, representatives, 

employees, attorneys, successors, and assigns, and any and all persons in active concert or 

participation with any of them who have received actual notice of this Decree by personal 

service or otherwise, are enjoined under 21 U.S.C. § 332(a) from directly or indirectly 

manufacturing, processing, packing, labeling, holding, introducing or delivering for introduction 

into interstate commerce (including foreign commerce) the ____ or any other device that is 

adulterated within the meaning of 21 U.S.C. § 351(f)(1)(B), unless and until:

A. An approved investigational device exemption ("IDE") by FDA, filed 

under 21 U.S.C. § 360j(g) and 21 C.F.R. § 812, for such device is in effect, and the use 

and distribution of the device conforms strictly to those requirements; or
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B. There is an FDA approved application for premarket approval 

(PMA) filed under 21 U.S.C. § 360e; or

C. FDA has received a premarket notification as required by 21 U.S.C. 

§ 360(k) (also referred to as 510(k) submission) for the device and has advised 

Defendants in writing pursuant to 21 U.S.C. § 360c(i)(1)(A) that the device is 

substantially equivalent to a predicate device.

II. If, at any time after entry of this Decree, FDA determines, based on the results of 

an inspection, the analysis of a sample, a report or data prepared or submitted by Defendants, 

or any other information, that Defendants have failed to comply with any provision of this 

Decree, have violated the Act or its implementing regulations, or that additional corrective 

actions are necessary to achieve compliance with this Decree, the Act, or its implementing 

regulations, FDA may, as and when it deems necessary, order Defendants in writing to take 

appropriate corrective actions, including, but not limited to, the following:

A. Cease all manufacturing, processing, packing, repacking, labeling, 

holding, and/or distributing any or all device(s);

B. Recall, at Defendant’s expense, any device that is adulterated, 

misbranded, or otherwise in violation of this Decree, the Act, or its implementing 

regulations;

C. Revise, modify, or expand any report(s) or plan(s) prepared 

pursuant to this Decree;

D. Submit additional reports or information to FDA;

E. Submit any application or any supplement to an existing device 

application to FDA;

F. Issue a safety alert; and/or

G. Take any other corrective actions as FDA, in its discretion, deems 

necessary to bring Defendants into compliance with this Decree, the Act, or its 

implementing regulations.

DEVICE CGMP

I. Upon entry of this Decree, Defendants and each of their officers, directors, agents, 

employees, representatives, attorneys, successors, and assigns, and any and all persons in 

active concert or participation with any of them who have received actual notice of this Decree 

by personal service or otherwise, are enjoined from manufacturing, processing, packing, 

labeling, and distributing any device (including components) unless and until Defendants:

A. Defendants' methods, facilities, and controls used to manufacture, process, 

pack, label, and distribute devices are established, operated, and administered in 
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compliance with the requirements of CGMP and the QS regulation, 21 C.F.R. Part 820, 

including but not limited to the following:

1) Establishing and implementing adequate written procedures for finished 

device acceptance to ensure that each production run, lot, or batch of finished 

devices meets acceptance criteria;

2) Establishing and implementing adequate written procedures to control 

product that does not conform to specified requirements;

3) Establishing and implementing adequate quality requirements that must 

be met by suppliers, contractors, and suppliers, and adequate written procedures 

to ensure that all purchased or otherwise received products and services 

conform to specified requirements;

4) Developing, conducting, controlling, and monitoring production 

processes to ensure that device conform to their specifications;

5) Adequately validating processes whose results cannot be fully verified 

by subsequent inspection and testing, and establishing and implementing 

adequate written procedures for monitoring and controlling process parameters 

for validated processes to ensure that specified requirements continue to be met;

6) Establishing and implementing adequate written procedures to prevent 

contamination of equipment or product by substances that could reasonably be 

expected to have an adverse effect on product quality;

7) Establishing and implementing adequate written procedures to control 

environmental conditions that could reasonably be expected to have an adverse 

effect on product quality;

8) Establishing and implementing adequate requirements for the health, 

cleanliness, personal practices, and clothing of personnel;

9) Establishing and implementing adequate written procedures for 

identifying, documenting, validating or verifying, reviewing, and approving design 

changes prior to their implementation;

10) Establishing and implementing adequate design validation 

requirements to ensure that devices conform to defined user needs and intended 

uses; and

11) Establishing and implementing adequate written procedures for 

identifying employee training needs and for ensuring that all personnel are 

trained to adequately perform their assigned responsibilities.
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B. Defendants develop and implement adequate written Medical Device 

Reporting (MDR) procedures in compliance with 21 C.F.R. Part 803.

C. Defendants recall at their own expense ___________ [which devices from 

which time frame?]

D. Defendants select and retain, at Defendants' expense, an independent 

person or persons (the "expert(s)"), who is qualified by education, training, and 

experience to evaluate whether Defendants are in compliance with CGMP/QS 

regulation requirements as set forth at 21 C.F.R. Part 820 and the MDR reporting 

requirements set forth at 21 C.F.R. Part 803. The expert(s) shall be without personal or 

financial ties (other than the consulting agreement between the parties) to any officer or 

employee of Defendants or their immediate families. Defendants shall notify FDA in 

writing of the identity of the expert(s) as soon as they retain such expert(s), and the 

expert(s) shall:

1) Determine whether Defendants are in compliance with the CGMP/QS 

regulation requirements as set forth at 21 C.F.R. Part 820 and the MDR 

requirements set forth at 21 C.F.R. Part 803; and

2) Provide FDA with a complete and adequate written evaluation of 

Defendants' compliance with CGMP and 21 C.F.R. Parts 820 and 803.

E. Defendants submit an adequate written report of all corrections Defendants 

have made to come in to compliance with the requirements of the Act and 21 C.F.R. 

Parts 820 and 803.

F. Defendants submit a written report to FDA documenting what steps have 

been taken to ensure that Defendants' employees and managers are adequately trained 

in the CGMP/QS regulation and MDR requirements applicable to their assigned 

responsibilities and positions.

G. The expert(s) has certified to FDA in writing that Defendants are in 

compliance with the Act, CGMP, and 21 C.F.R. Parts 820 and 803.

H. Duly authorized FDA representatives have made inspections, as and when 

FDA deems necessary and without prior notice, of Defendants' facilities, including 

buildings, equipment, personnel, finished and unfinished materials, containers and 

labeling, and all records relating to the manufacturing, packing, labeling and distributing 

of devices to determine whether the requirements of paragraph ___________ of this 

Decree have been met. Such inspection shall commence no later than _____ days 

after receipt of the reports and certifications pursuant to paragraph _______ above; and

I. FDA notifies Defendants in writing that they may commence manufacturing, 

packing, labeling, and distributing medical devices.
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DRUG (OR DEVICE) CGMP

I. Upon entry of this Decree, Defendants and each and all of their directors, 

officers, agents, representatives, employees, attorneys, successors, and assigns, and any and 

all persons in active concert or participation with any of them who receive actual notice of this 

Decree by personal service or otherwise, are permanently restrained and enjoined under 21 

U.S.C. § 332(a) from directly or indirectly manufacturing, processing, packing, labeling, 

holding, or distributing any articles of drug unless and until:

A. Defendants' methods, facilities, and controls used to manufacture, 

process, pack, label, hold, and distribute drugs are established, operated, and 

administered in compliance with CGMP. 21 U.S.C. § 351(a)(2)(B) and 21 C.F.R. Parts 

210 and 211;

B. Defendants retain, at Defendants' expense, an independent person 

or persons (the "CGMP expert"), who is without any personal or financial ties (other 

than the retention agreement) to Defendants and their families, and who, by reason of 

background, training, education, or experience, is qualified to inspect Defendants' drug 

manufacturing facilities to determine whether the methods, facilities, and controls are 

operated and administered in conformity with CGMP. Defendants shall notify the United 

States Food and Drug Administration ("FDA") in writing of the identity and qualifications 

of the CGMP expert as soon as they retain such expert;

C. The CGMP expert performs a comprehensive inspection of 

Defendants' facilities and the methods and controls used to manufacture, process, pack, 

label, hold, and distribute drugs to determine whether they are in compliance with 

CGMP. This inspection shall include, at a minimum, the following:

(1) An evaluation as to whether the Defendants have established a 

comprehensive written quality assurance (QA) and quality control (QC) program 

(QA/QC program) that is adequate to ensure continuous compliance with 

applicable laws and regulations.

(2) The CGMP expert shall determine whether the QA/QC program, at 

a minimum:

a. Addresses all facets of compliance monitoring and 

trend analyses, and internal audit procedures, and confirms that 

Defendants' Quality Unit is adequately trained and staffed to evaluate 

CGMP compliance and prevent and correct future deviations from CGMP;

b. Includes procedures to ensure that the Defendants, in 

a timely manner, thoroughly investigate any unexplained discrepancy or 

the failure of a batch of drug or its components to meet any of the 

product's or component's specifications, including the extension of such 

investigation to other batches of the same drug product and other drug 
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products that may have been associated with the specific failure or 

discrepancy, and to take required and timely corrective actions for all 

products that fail to meet their specifications;

c. Establishes mechanisms to ensure that written 

standard operating procedures (SOPs) specifying the responsibilities and 

procedures applicable to QA or QC personnel are updated, followed, and 

periodically reviewed by the Quality Unit to ensure that they reflect current 

and CGMP compliant-practices;

d. Includes written SOPs necessary to ensure that all 

facets of compliance monitoring are reviewed and controlled by QA 

personnel; and

e. Includes written SOPs to ensure that the Defendants' 

QA personnel participate in or monitor the implementation and verification 

of corrective actions to prevent future occurrences of such deviations 

and/or problems and there are systems to ensure that such written SOPs 

are continuously followed;

D. The CGMP expert certifies in writing to FDA that:

(1) He or she has inspected Defendants' facilities, methods, processes, 

and controls;

(2) All CGMP deviations brought to Defendants' attention since _____ 

by FDA, the CGMP expert, or any other source, including but not limited to any 

experts hired prior to the entry of this Decree, have been corrected; and

(3) Such facilities, methods, processes, and controls are in compliance 

with the requirements of CGMP. As part of this certification, the CGMP expert 

shall include a full and complete detailed report of the results of his or her 

inspection;

E. Defendants report to FDA in writing the actions they have taken to:

(1) Correct the CGMP deviations brought to Defendants' attention by 

FDA, the CGMP expert, and any other source, including but not limited to any 

experts hired prior to the entry of this Decree; and

(2) Ensure that the methods used in, and the facilities and controls 

used for, manufacturing, processing, packing, labeling, holding, and distributing 

drugs are operated and will be continuously administered in conformity with 

CGMP.
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F. Defendants recall and destroy in accordance with the procedures 

provided in paragraph ___ all drugs that they manufactured, processed, packed, 

labeled, held, or distributed prior to____________;

G. FDA representatives inspect Defendants' facilities to determine 

whether the requirements of this Decree have been met, and whether Defendants' 

facilities are operating in conformity with CGMP, the Act, and its implementing 

regulations; and

H. FDA notifies Defendants in writing that Defendants appear to be in 

compliance with the requirements set forth in subparagraphs_________. In no 

circumstance will FDA's silence be construed as a substitute for written notification.

II. Within fifteen (15) calendar days of entry of this Decree, Defendants shall, under 

FDA supervision, destroy all drugs in Defendants' possession, custody, and/or control that are 

adulterated because they were not manufactured, processed, packed, labeled, held, and/or 

distributed in accordance with CGMP. Defendants shall reimburse FDA for the supervision of 

the destruction, including Defendants' destruction of products since ________, and prior to 

entry of this Decree, at the rates set forth in paragraph ____ of this Decree. Defendants shall 

not dispose of any drugs in a manner contrary to any federal, state, or local laws, including but 

not limited to, the National Environmental Policy Act of 1969.

III. After Defendants have complied with paragraphs __________ and FDA has 

notified them pursuant to paragraph_____, Defendants shall retain an independent person or 

persons who shall meet the criteria described in paragraph _____ to conduct audit inspections 

of their drug manufacturing operations no less frequently than once every six (6) months for a 

period of no less than five (5) years (hereinafter, "auditor"). If Defendants choose, the auditor 

may be the same person or persons retained as the CGMP expert in paragraph_____.

A. At the conclusion of each audit inspection, the auditor shall prepare 

a detailed written audit report ("audit report") analyzing whether Defendants are in 

compliance with CGMP and identifying any deviations from CGMP ("audit report

observations"). As a part of every audit report, except the first audit report, the auditor 

shall assess the adequacy of corrective actions taken by Defendants to correct all 

previous audit report observations. The audit reports shall be delivered 

contemporaneously to Defendants and FDA by courier service or overnight delivery 

service, no later than fifteen (15) business days after the date the audit inspection(s) is 

completed. In addition, Defendants shall maintain the audit reports in separate files at 

their facility and shall promptly make the audit reports available to FDA upon request.

B. If an audit report contains any observations indicating that 

Defendants are not in compliance with CGMP, Defendants shall, within thirty (30) 

calendar days of receipt of the audit report, correct those observations, unless FDA 

notifies Defendants that a shorter time period is necessary. If, after receiving the audit 

report, Defendants believe that correction of the deviations will take longer than thirty 
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(30) calendar days, Defendants shall, within ten (10) calendar days of receipt of the 

audit report, submit to FDA in writing a proposed schedule for completing corrections 

("correction schedule"). The correction schedule must be reviewed and approved by 

FDA in writing prior to implementation by Defendants. In no circumstance will FDA's 

silence be construed as a substitute for written approval. Defendants shall complete all 

corrections according to the approved correction schedule. Within thirty (30) calendar 

days of Defendants' receipt of an audit report, unless FDA notifies Defendants that a 

shorter time period is necessary, or within the time period provided in a correction 

schedule approved by FDA, the auditor shall review the actions taken by Defendants to 

correct the audit report observations. Within five (5) business days of beginning that 

review, the auditor shall report in writing to FDA whether each of the audit report 

observations has been corrected and, if not, which audit report observations remain 

uncorrected.

IV. If, at any time after entry of this Decree, FDA determines, based on the results of 

an inspection, the analysis of a sample, a report or data prepared or submitted by Defendants, 

the CGMP expert, the auditor, or any other information, that Defendants have failed to comply 

with any provision of this Decree, have violated CGMP, the Act, or its implementing 

regulations, or that additional corrective actions are necessary to achieve compliance with this 

Decree, CGMP, the Act, or its implementing regulations, FDA may, as and when it deems 

necessary, notify Defendants in writing of the noncompliance and order Defendants to take 

appropriate corrective action, including, but not limited to, ordering Defendants to immediately 

take one or more of the following actions:

A. Cease all manufacturing, processing, packing, labeling, holding, 

and/or distributing any or all drug(s);

B. Recall, at Defendants' own expense, any drug that is adulterated or 

otherwise in violation of this Decree, CGMP, the Act, or its implementing regulations;

C. Revise, modify, or expand any report(s) or plan(s) prepared 

pursuant to this Decree;

D. Submit additional reports or information to FDA;

E. Issue a safety alert; and/or

F. Take any other corrective actions as FDA, in its discretion, deems 

necessary to protect the public health or to bring Defendants into compliance with this 

Decree, CGMP, the Act, or its implementing regulations.

TISSUE RESIDUE

I. Defendants and each and all of their officers, agents, representatives, employees, attorneys, 

successors, assigns, and any and all persons in active concert or participation with any of 

them who have received notice of this Decree, are hereby permanently restrained and 
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enjoined under the provisions of 21 U.S.C. § 332(a) from directly or indirectly: introducing and 

causing to be introduced into interstate commerce, and delivering and causing to be delivered 

for introduction into interstate commerce, any article of food, within the meaning of 21 U.S.C. § 

321(f), consisting of animals and their edible tissues; and, subject to paragraph___, 

administering any new animal drug, within the meaning of 21 U.S.C. § 321(v), to any animal 

while such drug is held for sale after shipment in interstate commerce, unless and until the 

following occur:

A. Defendants have established and implemented a system that ensures that 

each of the animals that they acquire, purchase, hold, transport, sell, consign, or 

distribute is individually and permanently identified by tag number;

B. Defendants have established and implemented a written record-keeping 

system that prevents them from selling, consigning, or distributing animals whose edible 

tissue contains new animal drugs in amounts above the levels permitted by law. This 

system shall include, but not be limited to, keeping written records on every animal to 

which Defendants administer drugs. These records shall include, at a minimum: (1) the 

identity of each animal that Defendants medicate; (2) the date of each administration of 

each drug to each animal; (3) the name of each drug administered; (4) the dosage of 

each drug administered; (5) the route of administration of each drug; (6) the written 

order of a licensed veterinarian for each drug used, if applicable; (7) the name of the 

person administering each drug; (8) the established withdrawal period for each drug 

administered; (9) the date the withdrawal period will terminate for each drug; (10) the 

date each medicated animal is shipped for slaughter or leaves Defendants’ control; and 

(11) the name and address of the purchaser, consignee, or recipient of each medicated 

animal that is shipped for slaughter or leaves Defendants’ control;

C. Defendants have established and implemented a system that ensures that 

their use of new animal drugs conforms to the uses approved by the United States Food 

and Drug Administration (“FDA”) as set forth in the drugs’ approved labeling or, for new 

animal drugs used in an extra-label manner, to the lawful written orders of a licensed 

veterinarian and in compliance with 21 U.S.C. § 360b(a)(4)(A) and 21 C.F.R. Part 530. 

This system shall include, at a minimum, measures to prevent: (1) the use of drugs in 

Defendants’ animals that are not approved for use in that species or not approved for 

the disease or other condition for which the animal is being medicated, unless such use 

is in accordance with the lawful written order of a licensed veterinarian within the 

context of a valid veterinarian-client-patient relationship and is in compliance with 21 

C.F.R. Part 530; (2) the administration of drugs in excess of the approved dosage, 

unless such administration is in accordance with the lawful written order of a licensed 

veterinarian within the context of a valid veterinarian-client-patient relationship and is in 

compliance with 21 C.F.R. Part 530; (3) the administration of drugs by a non-approved 

route unless such administration is in accordance with the lawful written order of a 

licensed veterinarian within the context of a valid veterinarian-client-patient relationship 

and is in compliance with 21 C.F.R. Part 530; and (4) the sale and delivery for slaughter 
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of medicated animals before the expiration of the withdrawal period, as specified in the 

approved labeling or, for new animal drugs used in an extra-label manner, in the lawful 

written order of a licensed veterinarian within the context of a valid veterinarian-clientpatient relationship and in compliance with 21 C.F.R. Part 530);

D. Defendants have established and implemented a drug inventory and 

accountability system that prevents them from selling, consigning, or distributing 

animals with illegal new animal drug residues. This system shall include a written 

record for each drug that Defendants purchase or receive for medicating their animals, 

which record shall include, at a minimum: (1) the name of the drug; (2) the date of 

purchase or receipt of the drug; (3) the quantity, strength, and form of the drug; (4) the 

expiration date of the drug; (5) the name and address of the seller or supplier of the 

drug; (6) the date each drug is administered; and (7) the amount and method of each 

administration of each drug. In addition, the inventory and accountability system shall 

include periodic checks of inventory and records, no less frequently than once every 

fourteen (14) calendar days, to ensure that records accurately document the drugs 

currently on hand and the disposition of all drugs purchased or received;

E. Defendants have established and implemented a quarantine or segregation 

system that ensures ready distinction between medicated and unmedicated animals 

and that prevents Defendants from selling, consigning, or delivering for slaughter for 

use as food any animal with illegal new animal drug residues;

F. Defendants have established and implemented a system that ensures that 

each animal that has been medicated is not directly or indirectly sold, consigned, or 

delivered for immediate or ultimate slaughter before expiration of the withdrawal period 

(specified in the approved labeling or, for new animal drugs used in an extra-label 

manner, in the lawful written order of a licensed veterinarian and in compliance with 21 

U.S.C. § 360b(a)(4)(A) and 21 C.F.R. Part 530). This system shall also ensure that 

each purchaser, consignee, or recipient receives, prior to accepting any animal, a 

written statement from Defendants certifying either that any animal that has been 

medicated has also been withdrawn for the appropriate time period or that the animal 

has not been medicated. This written statement shall also include the date(s) on which 

the animal was medicated, each drug with which the animal was medicated, the 

required withdrawal period for each drug, and the date(s) on which the withdrawal 

period(s) expired. Defendants shall, prior to selling any animal, obtain the signature of 

the purchaser, consignee, or recipient documenting date of receipt of the statement 

from Defendants. Defendants shall keep, as part of their records, a copy of the signed 

written statement described in this paragraph;

G. Defendants have established and implemented a system to identify the 

source of each animal that they purchase or transport and to document whether the 

animal has been medicated, the date of medication, the drug used, and the withdrawal 

period for the drug;
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H. Defendants have reported to FDA in writing the steps they have taken to 

comply with paragraphs________;

I. FDA has inspected Defendants’ operations, including all records relating to the 

medication, purchase, sale, consignment, and distribution of food-producing animals;

J. Defendants have paid for the costs of the inspections, as described in 

paragraph_____; and

K. FDA has notified Defendants in writing that they appear to be in compliance 

with the requirements of paragraphs _____________ of this Decree

II. Prior to obtaining written notification from FDA as specified in paragraph______, 

Defendants may administer drugs to an ill food-producing animal that they own, but only after 

the animal has been examined by a licensed veterinarian and the veterinarian has diagnosed 

the animal and prescribed that drug for that animal. Within ten (10) calendar days after the 

drug is administered to Defendants’ animals pursuant to this paragraph, Defendants shall 

provide FDA with copies of the veterinarian’s diagnosis, prescription, and receipts for treatment 

(or the equivalent)

III. Defendants shall maintain all records described in paragraph ______ for each animal for a 

period of at least two (2) years after the date that the animal is sold, consigned, or delivered for 

slaughter. These records shall be made available immediately to FDA upon request for 

purposes of inspection and copying.

IV. After Defendants receive written notification from FDA as specified in paragraph 

________, Defendants and each and all of their officers, agents, representatives, employees, 

attorneys, successors, assigns, and any and all persons in active concert or participation with 

any of them, are permanently restrained and enjoined from directly or indirectly doing and

causing to be done any of the following acts:

A. Introducing and delivering for introduction into interstate commerce any article 

of food, within the meaning of 21 U.S.C. § 321(f), that is adulterated within the meaning 

of 21 U.S.C. §§ 342(a)(2)(C)(ii) or 342(a)(4);

B. Administering any article of drug, within the meaning of 21 U.S.C. 321(g), to 

any food-producing animal unless the administration conforms to the drug’s labeled 

conditions for use or to the lawful written order of a licensed veterinarian within the 

context of a valid veterinarian-client-patient relationship and in compliance with 21 

C.F.R. Part 530;

C. Doing any act with respect to any article of drug, within the meaning of 21 

U.S.C. § 321(g), if the act is done while such drug is held for sale after shipment in 

interstate commerce and results in the drug being adulterated within the meaning of 21 

U.S.C. § 351(a)(5); and
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D. Failing to implement and continuously maintain the requirements of this 

Decree.

V. Upon request, Defendants shall promptly provide any information and records to FDA 

regarding the sale, consignment, distribution, or medication of any animal.

VI. If, based on the results of any inspection or analysis conducted after the inspection 

described in paragraph______ or any other information, FDA finds that any Defendant is not in 

compliance with the requirements of this Decree, the Act, and FDA regulations, FDA may, as 

and when it deems necessary, notify Defendants in writing of the non-compliance and may 

require that Defendants immediately take one or more of the following actions:

A. Cease selling and delivering, and causing to be sold and delivered, any article 

of food within the meaning of 21 U.S.C. § 321(f);

B. Cease administering to animals any new animal drug, within the meaning of 

21 U.S.C. § 321(v), except under the terms specified in paragraph___; and

C. Take any other corrective actions as FDA deems necessary to bring 

Defendants into compliance with this Decree, the Act, and FDA regulations, including, 

but not limited to, requiring that Defendants re-institute or re-implement any of the 

requirements in paragraph __ of this Decree.

Upon receipt of such notification, Defendants shall immediately and fully comply with the terms 

of the notice. Any cessation of operations or other action ordered by FDA as described above 

shall continue until Defendants receive written notification from FDA that Defendants appear to 

be in compliance with the terms of this Decree and that they may resume operations.

Animal Drug CGMP

I. Upon entry of this Decree, the defendants and each and all of their officers, agents, 

employees, successors, assigns, and attorneys, and all persons in active concert or 

participation with any of them who receive notice of this Decree, are permanently restrained 

and enjoined under the provisions of 21 U.S.C. § 332(a) from directly and indirectly 

manufacturing, processing, packing, labeling, holding, and distributing any animal drug at their 

facilities located at ______________________________________ (and any other location or 

any new location at which the defendants manufacture, process, pack, label, hold, or distribute 

animal drugs), unless and until all the following occur:

A. The defendants’ methods, facilities, and controls used to 

manufacture, process, pack, label, hold, and distribute animal drugs are established, 

operated, and administered in compliance with CGMP requirements within the meaning 

of 21 U.S.C. § 351(a)(2)(B) and 21 C.F.R. Parts 210 and 211;

B. The defendants establish and implement a quality assurance and 

quality control program to ensure that the methods, facilities, and controls used to 
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manufacture, process, pack, label, hold, and distribute animal drugs are established, 

operated, and administered in continuous compliance with CGMP. The defendants 

shall assign responsibility and authority for monitoring quality assurance and quality 

control at the defendants’ facilities on a continuous basis to an individual who is 

appropriately qualified;

C. The defendants retain, at their expense, an independent person or 

persons (the “expert”), to make inspections of their animal drug manufacturing 

operations to determine whether their methods, facilities, and controls are operated and 

administered in conformity with CGMP. The expert shall be qualified by education, 

training, and experience to conduct the inspections, and shall be without personal or 

financial ties (other than a consulting agreement) to the defendants or their immediate 

families. The defendants shall notify the United States Food and Drug Administration 

(FDA) in writing of the identity and qualifications of the expert as soon as the defendants 

retain the expert;

D. The expert performs a comprehensive inspection of the defendants’ 

animal drug manufacturing operations. The expert shall determine whether the 

defendants’ facilities and the methods and controls used to manufacture, process, pack, 

label, hold, and distribute animal drugs are in compliance with CGMP. The expert shall 

also evaluate whether the defendants have established and implemented adequate 

quality assurance and quality control measures to ensure continuous compliance with 

CGMP;

E. The expert certifies in writing to FDA that: (1) he or she has 

inspected the defendants’ animal drug manufacturing operations; (2) all CGMP 

deviations brought to the defendants’ attention by FDA since__________, or by the 

expert, or through any other source have been corrected; and (3) the defendants’ 

facilities, methods, and controls are in compliance with CGMP. Among others, the 

CGMP deviations previously brought to the defendants’ attention by FDA relate to the 

requirements in: 21 C.F.R. §§ 211.22, 211.25(a), 211.42(c)(10)(v), 211.67(a), 

211.67(b), 211.100(a), 211.100(b), 211.110(a), 211.113(b), 211.160(b), 211.160(b)(4), 

211.165(d), 211.165(e), 211.165(f), 211.166(a)(3), 211.170(b), and 211.192. As part of 

the expert’s certification, the expert shall include a complete and detailed written report 

with the results of his or her inspection;

F. The defendants report to FDA in writing the actions they have taken 

to (1) correct the CGMP deviations brought to their attention by FDA, the expert, and 

any other source, and (2) ensure that the methods used in, and the facilities and 

controls used for, manufacturing, processing, packing, labeling, holding, and distributing 

animal drugs at their facilities will remain in continuous compliance with CGMP;

G. The defendants recall, as FDA deems necessary, all animal drugs 

that are within the possession, custody, or control of the defendants and their 

distributors;
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H. The defendants destroy, under FDA supervision, such in-process 

materials and finished animal drug products as FDA shall designate that were 

manufactured, processed, packed, held, labeled, or distributed at the defendants’ 

facilities, and are within the defendants’ possession, custody, or control, including all 

animal drugs to be recalled pursuant to Paragraph_____. The defendants shall not 

dispose of animal drugs in a manner contrary to any federal, state, or local laws, 

including the National Environmental Protection Act of 1969;

I. FDA, in its discretion and without prior notice, inspects the 

defendants’ facilities to determine whether the defendants are operating their facilities in 

conformity with the Act, CGMP, and this Decree;

J. The defendants pay the costs of any supervision, inspections, 

analyses, examinations, and reviews that FDA deems necessary to evaluate the 

defendants’ compliance with the terms of Paragraph____; and

K. FDA notifies the defendants in writing that they appear to be in 

compliance with the requirements set forth in Paragraphs ________ and that they are 

authorized to resume manufacturing, processing, packing, labeling, holding, and 

distributing animal drugs

II. Upon resuming operations after completing the requirements in Paragraph____, the 

defendants shall meet the following requirements:

A. The defendants shall retain an independent person or persons (the “auditor”) 

to conduct audit inspections of their animal drug manufacturing operations not less than 

once every six (6) months for a period of five (5) years. The auditor shall be qualified by 

education, training, and experience to conduct such inspections, and shall be without 

personal or financial ties (other than the consulting agreement) to the defendants or 

their immediate families. If the defendants choose, the auditor may be the same person 

or persons retained as the expert in Paragraph ______.

B. At the conclusion of each audit inspection, the auditor shall prepare 

a written audit report (the “audit report”) analyzing whether the defendants are in 

compliance with the Act, CGMP, and this Decree, and identifying any deviations from 

CGMP (“audit report observations”). As a part of every audit report, except the first 

audit report, the auditor shall assess the adequacy of corrective actions taken by the 

defendants to correct all previous audit report observations. The audit reports shall be 

delivered contemporaneously to the defendants and FDA by courier service or overnight 

delivery service, no later than ten (10) business days after the date the audit inspections 

are completed. If any audit report identifies CGMP deviations, FDA may, in its 

discretion, require that the five (5)-year auditing cycle be extended or begin anew. In 

addition, the defendants shall maintain the audit reports in separate files at their facility 

and shall promptly make the audit reports available to FDA upon request.
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C. If an audit report contains any audit report observations indicating 

that the defendants are not in compliance with the Act, CGMP, and this Decree, the 

defendants shall, within thirty (30) calendar days of receipt of the audit report, correct 

those observations, unless FDA notifies the defendants that a shorter time period is 

necessary. If, after receiving the audit report, the defendants believe that correction of 

the deviations will take longer than thirty (30) calendar days, the defendants shall, within 

five (5) business days of receipt of the audit report, submit to FDA in writing a proposed 

schedule for completing corrections (“correction schedule”) and provide justification 

describing why the additional time is needed. The correction schedule must be 

reviewed and approved by FDA in writing prior to implementation by the defendants. 

The defendants shall complete all corrections according to the approved correction 

schedule. Within thirty (30) calendar days of the defendants’ receipt of an audit report, 

unless FDA notifies the defendants that a shorter time period is necessary, or within the 

time period provided in a correction schedule approved by FDA, the auditor shall review 

the actions taken by the defendants to correct the audit report observations. Within ten 

(10) business days of beginning that review, the auditor shall report in writing to FDA 

whether each of the audit report observations has been corrected and, if not, which 

audit report observations remain uncorrected.

III. If, at any time after entry of this Decree, FDA determines, based on the results of 

an inspection, sample analysis, report, or other information, that the defendants have failed to 

comply with any provision of this Decree, have violated CGMP or the Act, or that additional 

corrective actions are necessary to achieve compliance with this Decree, CGMP, or the Act, 

FDA may, as and when it deems necessary, issue a directive notifying the defendants in 

writing of the noncompliance and ordering the defendants to take appropriate action, including 

but not limited to ordering the defendants immediately to take one or more of the following 

actions:

A. Cease manufacturing, processing, packing, labeling, holding, and 

distributing animal drugs unless and until the defendants receive written notification 

from FDA that the defendants appear to be in compliance with the Decree, CGMP, and 

the Act, and that the defendants may resume operations;

B. Recall any and all animal drugs;

C. Submit additional reports or information to FDA; and

D. Take any other corrective actions as FDA deems necessary to 

bring the defendants into compliance with this Decree, CGMP, and the Act, including 

but not limited to requiring that the defendants re-implement or re-institute any of the 

requirements of this Decree. The provisions of this paragraph shall be apart from, and 

in addition to, all other remedies available to FDA. The defendants shall pay all costs of 

recalls and other corrective actions, including the costs of FDA's supervision, 

inspections, investigations, analyses, examinations, and reviews to implement and 
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monitor recalls and other corrective actions, at the rates specified in Paragraph ______ 

of this Decree.

MEDICATED FEEDS

I. The defendants and each and all of their officers, agents, employees, 

successors, assigns, and attorneys, and any persons in active concert or participation with any 

of them (including individuals, directors, partnerships, corporations, subsidiaries, and affiliates) 

who receive actual notice of this Decree, are permanently restrained and enjoined under the 

provisions of 21 U.S.C. § 332(a) from directly or indirectly doing or causing the manufacture, 

processing, packing, labeling, holding, and distribution at their facilities located at 

_______________________ (and any new locations at which the defendants manufacture, 

process, pack, label, hold, or distribute medicated feeds), of any article of medicated feed 

unless and until:

A. The defendants establish, operate, and administer their feed 

manufacturing methods, facilities, and controls in conformity with the current good 

manufacturing practice ("CGMP") regulations for medicated feeds, 21 C.F.R. Part 225, 

and in a manner that ensures that all medicated feeds manufactured by the defendants 

are in accord with their label specifications and meet the assay limits set forth at 21 

C.F.R. § 558.4(d);

B. The defendants retain a person ("qualified person") who is without 

any personal or financial ties other than the consulting agreement to the defendants and 

their families and who, by reason of background, training, and experience, is qualified to 

make inspections of medicated feed manufacturing mills to determine whether the 

established methods, facilities, and controls are operated and administered in 

conformity with CGMP requirements, as specified in 21 C.F.R. Part 225; the defendants 

notify the United States Food and Drug Administration ("FDA") in writing of the person's 

identity and qualifications as soon as they retain the person; the qualified person 

inspects ____________ and the manner of operating________, and any new locations 

at which the defendants manufacture medicated feeds; and the qualified person certifies 

in writing to FDA that the requirements set forth in paragraph ____of this Decree have 

been met;

C. The defendants retain a laboratory other than one affiliated with 

__________ that, by reason of background, staff training, and experience, is qualified to 

analyze medicated feeds to determine whether the medicated feeds contain each drug 

that they purport or are represented to contain and said drug(s) meet(s) the assay limits 

set forth at 21 C.F.R. § 558.4(d); the defendants notify FDA in writing of the laboratory's 

identity as soon as they retain the laboratory; the defendants provide the laboratory with 

samples of each medicated feed, and the corresponding labels, manufactured at 

___________ that is still in the possession or under the custody or control of the 

defendants at the time this Decree is filed; and the laboratory analyzes all samples and 

simultaneously provides FDA and the defendants the results of all tests performed on 
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the samples, along with the labels, and certifies in writing whether the samples contain 

each drug that they purport or are represented to contain and whether such drug(s) 

meet(s) the assay limits set forth at 21 C.F.R. § 558.4(d);

D. The defendants, under the supervision of and in accordance with 

methods acceptable to FDA, recall, destroy, or otherwise bring into compliance with 

FDA regulations and the Act all adulterated lots of medicated feed identified by the 

laboratory analyses described in the preceding paragraph, including, when FDA deems 

necessary, medicated feed distributed to the defendants' agents, distributors, 

customers, or consumers;

E. The defendants report in writing to FDA all actions they have taken 

to ensure that the requirements in paragraph _______ of this Decree have been met;

F. FDA, as it deems necessary to evaluate the defendants' 

compliance with the terms of this Decree, conducts inspections of the defendants' 

facilities;

G. The defendants pay the costs of any supervision, inspection, 

analyses, examination, and review that FDA deems necessary to evaluate the 

defendants' compliance with the terms of this Decree; and

H. FDA notifies the defendants in writing that the defendants appear to 

be in compliance with the requirements in paragraphs________, FDA regulations, and 

the Act.

II. Upon resuming operations after completing the requirements of paragraph____, 

the defendants shall have the laboratory retained pursuant to paragraph _________ (or a 

similarly qualified laboratory) conduct the following analyses:

A. During the first six months of such operation, the defendants shall –

for each drug and drug combination the defendants use to manufacture medicated 

feeds – collect and have tested at least three representative samples of medicated feed 

to determine whether the drug(s) meet(s) the assay limits set forth at 21 C.F.R. § 

558.4(d). The sample collection and testing for each drug and drug combination the 

defendants use to manufacture medicated feeds shall be conducted under the following 

conditions:

1. The representative samples of medicated feed shall be collected 

and tested at periodic intervals throughout the six-month period;

2. One of the representative samples of medicated feed shall be 

collected from the batch that contains the first use of the drug or drug 

combination during the six-month period;
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3. The defendants shall have the laboratory simultaneously provide 

FDA and the defendants all results of the analyses; and

4. The defendants shall investigate and take corrective action for all 

medicated feeds determined by laboratory analyses to be outside the assay 

limits set forth at 21 C.F.R. § 558.4(d). All investigation and corrective action 

regarding medicated feeds found to be outside the assay limits set forth at 21 

C.F.R. § 558.4(d) shall be conducted pursuant to 21 C.F.R. § 225.58(d) and (e);

B. During the subsequent six-month period, the defendants shall 

repeat all of the requirements set forth at paragraph ______; and

C. After the first year, the defendants shall follow the medicated feed 

sampling and testing requirements set forth at 21 C.F.R. § 225.58

III. If, at any time after entry of this Decree, FDA determines, based on the results of 

an inspection, analysis of a sample or samples, or other information, that the defendants have 

failed to comply with any provision of this Decree, have violated FDA regulations or the Act, or 

that additional corrective actions are necessary to achieve compliance with this Decree, FDA 

regulations, or the Act, FDA may, as and when it deems necessary, notify the defendants in 

writing of the noncompliance and order the defendants to take appropriate action, including, 

but not limited to, ordering the defendants to immediately take one or more of the following 

actions:

A. Cease manufacturing, processing, packing, labeling, holding, or 

distributing any medicated feeds;

B. Recall all articles of medicated feed distributed at ___________ (or 

any new location), including feed distributed to the defendants' agents, distributors, 

customers, or consumers; or

C. Take any other corrective actions as FDA deems necessary to 

bring the defendants into compliance with this Decree, FDA regulations, and the Act, 

including, but not limited to, requiring that the defendants re-institute or re-implement 

any of the requirements in paragraphs ________ of this Decree. Upon receipt of such 

notification, the defendants shall immediately and fully comply with the terms of the 

notice. In the event that the defendants disagree with the terms of the notice, the 

defendants may appeal to this Court but shall continue to immediately and fully comply 

with the terms of the notice unless and until the Court modifies or overturns the notice. 

The defendants shall pay all costs of such recalls and corrective actions, including the 

costs of FDA supervision, inspections, analyses, examinations, review, travel, and 

subsistence expenses to implement recalls and other corrective actions, at the rates 

specified in paragraph ______ of this Decree. This provision shall be separate and 

apart from, and in addition to, all other remedies available to FDA.
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Exhibit 6-19

EXAMPLES OF COMPLAINT PROVISIONS

A. (Jurisdiction Model)

In this action, plaintiff, the United States of America, seeks a statutory injunction 

to restrain defendants, (Firm Name), and (Individual) , from manufacturing and distributing 

in interstate commerce an adulterated drug in violation of the Federal Food, Drug, and 

Cosmetic Act (Act), 21 U.S.C. 301 et seq. Jurisdiction to restrain such violations is granted 

to the district courts of the United States pursuant to 21 U.S.C. 332(a). This Court also has 

jurisdiction over this action pursuant to 28 U.S.C. 1331, 1337, and 1345. Venue is proper 

in this District pursuant to 28 U.S.C. 1391(b) and 1391(c).

B. (Models of Defendants' Responsibility/Authority--Drug Manufacturer)

Defendant (Firm) is a corporation incorporated under the laws of the 

Commonwealth of Pennsylvania with its principal place of business at (street address, City, 

State), within the jurisdiction of this Court

Defendant (Individual), an individual, is the president of (firm), and has overall responsibility 

for, and authority over, all operations of the corporation, including the manufacture and 

distribution of drug products

(Individual) performs his duties as president of (firm) at (street address, city, State).

The defendant, ______, an individual, is the Chief Executive Officer of ________. 

He is responsible for personnel and pharmaceutical operations of the firm. He performs 

those duties at __________.

The defendant, ______, an individual, is the Treasurer of ______. He is also a 

principal stockholder in ______. ______ is responsible for deciding whether the firm will 

market particular drugs. He shares final responsibility with ______ for authorizing financial 

expenditures. He performs those duties at ______.

C. (Model of Defendant Responsibility/Authority--Food Warehouse)

The defendant, _________, an individual, is secretary, treasurer, and manager of 

the corporation, performing his duties at ______. He has responsibility for and authority 

over the day-to-day operations at the warehouse, including the expenditure of funds for the 

proper operation and maintenance of the facility.

D. (Model of Defendants' Business Activities and Related Violations--

Unapproved New Drug)

The defendants have been and are now engaged, at the _____ facility at (Street 

address, City, State), in repacking, labeling, storing, promoting, and distributing in interstate 

commerce, the drug "________________, " which defendants promote through the use of 

literature accompanying (the drug) shipments to be used in the treatment, mitigation, cure, 

and prevention of various human diseases, including AIDS, lupus, and Parkinson's disease.

(Drug name) is a drug within the meaning of the FD&C Act, 21 U.S.C. 

321(g)(1)(B), because, based on the therapeutic claims made by the defendant, it is 

intended for use in the cure, mitigation, treatment, or prevention of disease in humans.
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________ is a new drug within the meaning of the FD&C Act, 21 U.S.C. 321(p), 

because it is not generally recognized by qualified experts as safe and effective for use 

under the conditions prescribed, recommended, or suggested in its labeling. There is not 

now nor has there ever been in effect an approval by the United States Food and Drug 

Administration (FDA) of an application, filed pursuant to 21 U.S.C. 355(i). __________ is, 

therefore, an unapproved new drug pursuant to 21 U.S.C. 355(a).

E. (Model of Defendant's Business Activities and Related Adulterations-

-Medicated Feeds)

The defendants have been and are now engaged at their plant at Street address, 

City, State, in manufacturing, processing, packing, labeling, storing, and holding for sale 

various articles of medicated feed, which articles of medicated feed are drugs within the 

meaning of 21 U.S.C. 321(g)(1) and new animal drugs within the meaning of 21 U.S.C. 

321(w) after shipment of one or more of the components of the feeds have moved in 

interstate commerce, and in distributing said articles of medicated feed in interstate and 

intrastate commerce.

Medicated feeds manufactured by defendants are adulterated while held for sale 

after shipment of one or more of their components in interstate commerce, within the 

meaning of 21 U.S.C. 351(a)(2)(B) in that the methods used in, and the facilities and 

controls used for, their manufacture, processing, packing, and holding do not conform to 

and are not operated and administered in conformity with current good manufacturing 

practice, 21 CFR 225, to assure that such drugs meet the safety requirements of the Act 

and have the identity and strength, and meet the quality and purity characteristics, which 

they purport or are represented to possess.

Certain medicated feeds manufactured by defendants, including those containing 

amprolium, lincomycin, and monensin in combination, and monensin, chlortetracycline, and 

sulfamethazine in combination, are also adulterated within the meaning of 21 U.S.C. 

351(a)(6) while held for sale after shipment of one or more of their components in interstate 

commerce, in that such feeds bear or contain new animal drugs, 21 U.S.C. 321(w), which 

are unsafe within the meaning of 21 U.S.C. 360b(a)(2) since no approvals of applications 

filed pursuant to 21 U.S.C. 360b(b) and 21 U.S.C. 360b(m) are in effect with respect to the 

use and intended use of such drugs.

Certain medicated feeds manufactured by defendants, including ________ and 

___ _______, are also adulterated within the meaning of 21 U.S.C. 351(c) while held for 

sale after shipment of one or more of their components in interstate commerce, in that their 

quality and purity fall below or their strength differs from that which they purport and are 

represented to possess because they do not contain the amount of drug declared on their 

label.

F. (Model of Defendants' Business Activities & Related Adulteration

1. Model-Food Processor)

The defendants have been and are now engaged in processing in-shell pecans 

into shelled pecan nut meats, a food within the meaning of 21 U.S.C. 321(f). The 

defendants routinely ship finished shelled nut meats to customers outside the State of 

_________.
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The shelled pecan nut meats being produced by defendants are adulterated 

within the meaning of 21 U.S.C. 342(a)(4) in that they have been prepared and packed 

under insanitary conditions whereby they may have become contaminated with filth.

2. (Another Model; Food Adulteration)

The wheat, when introduced or delivered for introduction into interstate 

commerce, is adulterated within the meaning of 21 U.S.C. 342(a)(2)(B), in that it bears 

and contains a pesticide chemical, malathion, which is unsafe within the meaning of 21 

U.S.C. 346a in that the malathion is present in excess of the tolerance prescribed for 

the pesticide chemical on the raw agricultural commodity under 21 U.S.C. 346a(a).

3. (Another Model; Device Adulteration/Misbranding)

All of the defendants' devices are adulterated within the meaning of 21 U.S.C. 

351(h) because the methods used in, and the facilities and controls used for, their 

manufacture, packing, and storage do not conform to FDA regulations establishing good 

manufacturing practice requirements, 21 CFR Part 820, promulgated under authority of

21 U.S.C. 360j(f)(1).

Certain of the defendants' in vitro diagnostic devices are misbranded within the 

meaning of 21 U.S.C. 352(f)(1) in that their labeling lacks adequate directions for use 

because the data required by regulation, 21 CFR 809.10(a)(5), to support the expiration 

dates appearing on the labeling of the devices either does not exist or has not been 

analyzed to verify the expiration period represented.

G. (Model for Inspectional Evidence--Food Processor)

Two recent inspections of __________ facility by FDA found insect infestation 

and other insanitary conditions that could cause the flour produced there to become 

contaminated with filth. During an inspection on April 23 and 24, 2003, moth cocoons and 

insect webbing were observed on each of the firm's three milling machines, and live insects 

were seen on walls in the milling room and on floors and walls of the packaging room. 

Similar insanitary conditions had been observed at a previous inspection on February 9, 

2002.

Inspections by the State of ___________ have also found continuing insect and 

rodent activity within __________'s facility. The __________ State Department of 

Agriculture ("_SDA") has inspected __________ at least five times since 2001 under a 

federal/state contract with FDA. _SDA investigators observed evidence of insect and/or 

rodent activity on three of these inspections.

Inspections conducted by FDA on ______, and ______, 20__, at the defendants' 

facility revealed insanitary conditions substantially similar to those found during the most 

recent inspection.

H. (Model for Previous Inspectional Evidence--Drug GMP)

Previous inspections of ______ establish that it has a consistent history of failure 

to comply with GMP. Inspections conducted by FDA from ______ to ______ , 20__, and 

from ______ to ______, 20__, at the defendants' plant revealed substantially similar, and 

equally serious, deviations from the GMP regulations as revealed during the ______, 20__, 
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inspection. (Also identify other written notifications given by FDA to the defendants about 

their violative conduct.)

I. (Model for Inspectional Evidence--Illegal Sale of Animal Drugs)

On ______, 20__, an FDA investigator inspected the defendants' facility to 

determine their activities with respect to the sale of prescription veterinary drugs and new 

animal drugs. A review of sales invoices and other records revealed that the defendants 

routinely sold prescription veterinary drugs without valid prescriptions, and sold new animal 

drug Type A medicated articles without having an unrevoked written statement that the 

purchasers held approved medicated feed applications for the use of such Type A 

medicated articles in animal feed. The inspection disclosed that the defendants had made 

numerous sales of prescription veterinary drugs, including oxytocin, dexamethasone, and 

Liquamycin, without a valid prescription or an order from a licensed veterinarian reduced to 

writing. The defendants had also made four sales of the new animal drug Type A 

medicated article Mecadox (carbadox) to three consignees for use in animal feed. At the 

time of these sales, the defendants did not have valid written statements from the 

purchasers that they were holders of approved medicated feed applications.

J. (Model for Charging 301(k))

Defendants violate 21 U.S.C. 331(k) by their acts of manufacturing, processing, 

packing, and holding, and by their acts of causing to be manufactured, processed, packed, 

and held, articles of food and drug, after one or more of the components of such foods and 

drugs have been shipped in interstate commerce, all of which acts result in the articles 

being adulterated as set out in paragraph _____ above, and being misbranded as set out in 

paragraph _____ above.

K. (Model for Charging 301(a))

Defendants violate 21 U.S.C. 331(a) by introducing and causing the introduction 

in interstate commerce of articles of device that are adulterated and misbranded as set 

forth in paragraph _____.

L. (Model for Charging 301(d))

The defendant, by introducing or delivering for introduction into interstate 

commerce __________, an unapproved new drug, has been and is in violation of 21 U.S.C. 

331(d).

M. (Affirming Need for Injunction)

1. Model

Despite having been warned by FDA that the distribution of __________ violates 

the Act, the defendants continue to repackage, label, store, distribute, and promote this 

product in the manner described (in the complaint) above.

2. (Another Model)

The defendants' history of sanitation control problems demonstrates their 

unwillingness and/or inability to maintain a sanitary food manufacturing facility. Both 

FDA and _SDA have warned defendants that the insanitary conditions at their facility 

might subject them to regulatory action. Notwithstanding these warnings, and 
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notwithstanding assurances from defendants that the sanitation problems would be 

remedied, the problems persist.

Based on the defendants' repeated course of conduct, it is evident that unless 

restrained by order of this Court, defendants may well continue to manufacture and 

distribute __________ in violation of the Act, 21 U.S.C. 331(a) and 331(k).

N. (Model Prayers)

WHEREFORE, PLAINTIFF PRAYS:

I. That the defendants, _______, a corporation, and ______, and ______, 

individuals, and each and all of their officers, agents, representatives, employees, 

successors or assigns, attorneys, and those persons in active concert or participation with 

them or any of them, be perpetually restrained and enjoined pursuant to 21 U.S.C. 332(a) 

from directly or indirectly doing or causing the introduction or delivery for introduction into 

interstate commerce of any drug that is a new drug within the meaning of 21 U.S.C. 321(p); 

and from directly or indirectly manufacturing, processing, packing, labeling, or holding for 

sale, after shipment of one or more of its components in interstate commerce, any drug that 

is a new drug within the meaning of 21 U.S.C. 321(p), unless and until:

A. An approved application filed pursuant to 21 U.S.C. 355(b) is 

effective with respect to said drug;

B. An acceptable notice of claimed investigational exemption filed 

pursuant to 21 U.S.C. 355(i) and regulation 21 CFR 312.1 is on file for such drug; or

C. FDA has advised defendants that the drug is not a "new drug."

II. That the plaintiff be granted judgment for its costs herein, and that the Court 

grant such other and further relief as the Court deems just and proper.

1. (Another Model)

WHEREFORE PLAINTIFF PRAYS:

I. That the defendants ______, a corporation, ______, and ______, individuals, 

and all of their officers, agents, representatives, employees, successors or assigns, 

attorneys, and all persons in active concert or participation with them or any of them, be 

preliminarily and perpetually restrained and enjoined from directly or indirectly introducing 

or causing the introduction into interstate commerce of any device, or holding for sale any 

device after shipment of one or more of its components in interstate commerce, unless and 

until defendants satisfy FDA that:

A. The labeling for the devices is not false or misleading; and

B. The methods, facilities, and controls for manufacturing, processing, 

packing, and labeling the devices are established, operated, and administered in 

conformity with FDA's GMP regulations for devices, 21 CFR Part 820.

II. That recalls of devices manufactured by the defendants shall be made as the 

FDA deems necessary.
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III. That the Court award plaintiff its costs herein, and such other and further relief as 

the Court deems just and proper.

(Another Model)

WHEREFORE PLAINTIFF respectfully requests that this Court:

I. Preliminarily and permanently enjoin the defendants, ______, a corporation, and 

______, an individual, and each and all of their directors, officers, agents, representatives, 

employees, successors or assigns, attorneys, and any and all persons in active concert or 

participation with them or any of them, from directly or indirectly doing or causing the 

introduction or delivery for introduction into interstate commerce of any adulterated food 

which has been received, prepared, packed, or held at the defendants' facility.

II. Order the defendants to recondition or destroy all food under their control, and 

render their warehouse facility suitable for handling foods, in the manner and to the extent 

FDA deems necessary.

III. Grant plaintiff its costs and such other further relief as the Court deems just and 

proper.
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(Model Signature Page)

Respectfully submitted,

NAME IN CAPS

Assistant Attorney General

Civil Division

NAME IN CAPS

United States Attorney

__________________

NAME IN CAPS

Assistant U.S. Attorney

Mail Address

City, State Zip

________________________

OF COUNSEL: NAME IN CAPS

Attorney

Office of Consumer Litigation

NAME IN CAPS Civil Division

Chief Counsel U.S. Department of Justice

Food and Drug Administration P.O. Box 386

Washington, D.C. 20044

NAME IN CAPS (202) 307-0047

Trial Attorney

Food and Drug Administration

5600 Fishers Lane

Rockville, MD 20857
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Exhibit 6-20

AFFIDAVIT/DECLARATION

(NOTE: FOR AFFIDAVIT FORM, SEE END OF THIS MODEL)

IN THE UNITED STATES DISTRICT COURT

FOR THE __________ DISTRICT OF ________

UNITED STATES OF AMERICA) ) Civil Action No.

)

Plaintiff, )

)

v. )

)

_______________, INC., a corporation, ) STATEMENT OF

NAME IN CAPS, and ) NAME IN CAPS

NAME IN CAPS, individuals )

)

)

Defendants. )

State of ________ )

County of _______ )

1. I am District/Division/Program Director, _______ Division, __________ Program, Food and 

Drug Administration, Department of Health and Human Services, Street Address, City, State.

2. I direct and supervise the day-to-day enforcement of the Federal Food, Drug, and Cosmetic 

Act for the United States Food and Drug Administration, __________ Division/Program, 

__________ Program which includes the States/Program of ________, ________, ________ 

and ________.

3. I am familiar with the investigation of Firm, Inc. performed by the _________ Division/

Program, and the laboratory at the _________ Office, Food and Drug Administration. The 

official records of the Food and Drug Administration, contained in the files located in the 

_______ Division/Program, establish the facts in this statement.

4. Firm, Inc. was incorporated in 1954 under the laws of the State of _________ and is now 

engaged in the manufacture of prescription and non-prescription drug products (tablets) 

primarily on the special order of customers who specify the formulation.

5. Firm, Inc., is presently doing business at street address, City, State Zip.

6. Individual A, President of Firm, Inc., presently resides at Street address, City, State.

7. Individual B, Production Manager for Firm, Inc. presently resides at Street address, City, 

State.

8. Inspection of Firm, Inc. during July 1999 revealed deviations from good manufacturing 

practices, including improper batch production records. A list of Observations was presented to 

and discussed with Individual A, who promised that corrections would be made.
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9. Inspection of Firm, Inc. during March-April 2000, revealed a continuation of the deviations 

previously brought to the attention of Individual A. A written List of Observations was presented 

to Mr. ________, Production Manager, who promised corrections on most of the observations.

10. On July 14, 2000, an Untitled Letter was issued to Individual A informing him that two lots 

of ascorbic acid tablets, 20214-4 and 20214-5, manufactured by Firm for private label 

distribution by a consignee in City, State, failed content uniformity testing. Lot 20214-4 

contained only 92.2% of the declared ascorbic acid and was therefore also subpotent.

11. Inspection of Firm, Inc. on November 2 through 11, 2001, revealed serious deviations from 

current good manufacturing practice regulations as they appear in Title 21, Code of Federal 

Regulations, Parts 210 and 211. At the conclusion of that inspection, a List of Observations, 

consisting of 54 deviations from good manufacturing practice regulations, a copy of which is 

appended as Exhibit A, was issued to Individual A and discussed with him and Individual B, 

Assistant Production Manager. Individual A stated during the discussion that Individual B was 

hired to assist the firm in complying with current good manufacturing practice regulations. The 

investigator informed Individual A and Individual B of their responsibilities under the Federal 

Food, Drug, and Cosmetic Act when manufacturing drug products and the penalties that can 

be invoked for violating said Act. Individual A stated that he intended to bring Firm, Inc. into 

compliance with current good manufacturing practice regulations.

12. A sample of sugar coated yellow oval tablets of conjugated estrogen 1.25 mg 

manufactured by Firm was collected by __________ ORA investigator _____ ______ on 

November 3, 2001, during the course of his inspection of the firm. Analyses of the drug at the 

FDA ________ Laboratory and a headquarters laboratory revealed that the product was not 

only subpotent with respect to total conjugated estrogens (51.7% and 46.6%) but also failed to 

meet compendial standards for the relative amounts of two constituent estrogens.

13. As a result of the violative inspection November 2 through 11, 2001, a sample of 

Nitroglycerin tablets, among others, was collected at a consignee in City, State, by the Food 

and Drug Administration. Analysis of the sample revealed that seven of thirty tablets failed to 

meet prescribed potency requirements and on a check analysis three of thirty tablets were not 

within compendial limits. The article therefore did not conform to United States Pharmacopeia 

requirements for content uniformity. Furthermore, seventeen of eighteen tablets on original 

analysis and eighteen tablets on check analysis failed to comply with compendial disintegration 

requirements. Firm, Inc. was advised of these results and recalled and destroyed the lot.

14. A sample of lot 21244-1 of Potassium Sulfate tablets manufactured by Firm was collected 

by FDA in November 2001. Analysis revealed that this drug did not meet the requirements for 

disintegration of an enteric coated tablet as prescribed in the United States Pharmacopeia. 

Upon the firm's failure to recall this drug, seizure was accomplished on January 27, 2002, in 

the United States District Court for the ______ District of ____ (Docket #CA ____; FDC ____).

15. On December 23, 2001, a Warning Letter, a copy of which is appended as Exhibit B, was 

issued to Individual A. This letter outlined deviations from current good manufacturing practice 

regulations observed during the November 1998 inspection.

16. Inspection of February 1 through 9, 2002, made as a follow-up to the November 1998 

inspection, revealed a continued lack of compliance with good manufacturing practice 

regulations. Numerous deviations from current good manufacturing practice regulations were 

observed. A List of Observations, a copy of which is appended as Exhibit C, consisting of 79 
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items was presented to Individual A and discussed with him and Individual B, who was now 

Production Manager, and four other Firm, Inc. personnel. Individual A stated that he was 

aware of the seriousness of the situation. Individual A and Individual B agreed to make some 

corrections, many of them deviations previously called to their attention which they had failed 

to correct.

17. As a result of the violative inspection of February 1 - 9, 2002, a sample of __________ 

tablets manufactured by Firm was collected at a consignee in City, State, by FDA. Analysis 

revealed that the drug was subpotent in declared opium (67.2% original analysis and 64.8% by 

check analysis) and atropine sulfate (58% original analysis and 69.4% by check analysis). 

When notified of these results, Individual A stated he would not remove this lot from sale. Upon 

the firm's failure to recall this drug, seizure was recommended to the United States Attorney for 

the _________ District of _____.

18. A limited inspection was instituted March 11, 2002, to determine what corrections had 

been made in the firm's operation based upon the observations called to management's 

attention in February. Inspection revealed that while a few improvements had been made, 

there was a continuing lack of compliance with current good manufacturing practice 

regulations. A List of Observations consisting of 47 items, attached as Exhibit D, was 

presented to Individual A and discussed with him, with Individual B, and with Dr. __________, 

President of _________ Associates, Inc., a consultant to Firm, Inc.

19. During the course of the inspection instituted March 11, 2002, the investigators noted that 

two lots of __________ tablets had been returned by the consignee in City, State, because of 

visible deterioration.

I declare under penalty of perjury that the forgoing is true and correct.

Executed on__________________________.

NAME IN CAPS

District/Division/Program Director

If an affidavit, rather than a statement, is to be used, make the following changes:

1. Change the word STATEMENT to AFFIDAVIT.

2. Before item 1. add: " Before me, ______________, a Notary Public, personally appeared 

________, who, first being duly sworn, deposes and says:"

3. At the end, delete the last sentence and, under the signature add: "Subscribed and sworn 

to before me in the City and District aforesaid this day of______20__.

_________________________________

Notary Public

The end of the affidavit will then appear as follows:

19. During the course of the inspection instituted March 11, 2002, the investigators noted that 

two lots of ____________ tablets had been returned by the consignee in City, State, because 

of visible deterioration.
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NAME IN CAPS

District/Division/Program Director

Subscribed and sworn to before me in the City and District aforesaid this __ day of ____ 20__.

_____________________________

Notary Public
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Exhibit 6-21

MODEL LETTER BILLING CHARGES

Sample Number Date

INJ ___, FDC _____

Firm

Street Address

City, State, Zip Code

Sir/Madam:

The following costs have been incurred by your firm as a result of the Decree of 

Preliminary Injunction entered by the Court on _______.

Under the terms of that Decree, your firm is required to pay the costs of inspection and 

analytical work performed by FDA to insure compliance with the terms of the injunction.

Investigator's time 6 hrs. at $**.** per hr $XXX.XX

Mileage-Gov’t car 18 miles at $0.*** per mile $ X.XX

Analyst's time 5 hrs. at $**.** per hr $XXX.XX

Total Charges $XXX.XX

(* Note: Use rates of reimbursement specified in Consent Decree)

Please remit promptly a money order, bank draft, or certified check for $XXX.XX, made 

payable to the United States Treasury, attach to the enclosed copy of this letter, and 

return to this office.

Sincerely yours,

____________________________________

Director, Compliance Branch District/Division

Enc: cc this letter
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Exhibit 6-22

PETITION FOR ORDER TO SHOW CAUSE

UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF____________

UNITED STATES OF AMERICA, )

Plaintiff, )

)

v. ) Criminal Action No._______

)

NAME IN CAPS, )

and )

NAME IN CAPS, )

Corporations, )

)

and )

)

NAME IN CAPS, )

NAME IN CAPS, )

NAME IN CAPS, )

NAME IN CAPS, and )

NAME IN CAPS, )

Individuals, )

Defendants )

PETITION FOR ORDER TO SHOW CAUSE WHY DEFENDANTS 

SHOULD NOT BE HELD IN CRIMINAL CONTEMPT

Plaintiff, United States of America, hereby moves this Court for an Order to Show 

Cause why Firm A, Inc. (Firm A), and Firm B, Inc. (Firm B), corporations, and Individual A, 

Individual B, Individual C, Individual D, and Individual E, individuals (hereafter, collectively, the 

defendants) should not be adjudged in criminal contempt of a Consent Decree of Permanent 

Injunction (Decree) entered by this Court on April 25, 1999. In support of this Petition, the 

United States of America states as follows.

BACKGROUND

1. On April 7, 1999, the United States filed a Complaint for Injunction (1999 Complaint) 

against named defendants Firm A, Individual A, and another individual not named in this 

action, Ex. 1, along with a signed Consent Decree of Permanent Injunction (Decree). Ex. 2. 

Judge entered the Consent Decree on April 25, 1999. Id. 

Firm A was and is a manufacturer of devices within the meaning of the Federal Food, Drug, 

and Cosmetic Act (FDCA). 21 U.S.C. § 321(h). The FDCA defines a device as an "instrument, 

apparatus, implement, machine, ... or other similar or related article, including any component, 
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part, or accessory, which is ... intended for use in the diagnosis of disease or other conditions, 

or in the cure, mitigation, treatment, or prevention of disease in man ... ." 21 U.S.C. § 321(h).

2. The 1999 Complaint alleged that Firm A and Individual A were violating the FDCA by 

introducing or delivering for introduction into interstate commerce devices adulterated within 

the meaning of 21 U.S.C. § 351(h), and by manufacturing, packing, and storing devices after 

shipment of one or more of their components in interstate commerce under conditions that 

resulted in the devices becoming adulterated. 21 U.S.C. §§ 331(a) and (k). At that time, 

defendants manufactured several devices including, but not limited to, an electrosurgical 

device (the Electro Probe) and a silicone chin implant (the Axis Implant). See Ex. 1 ¶¶ 6-8.

The Electro Probe is used by doctors to control bleeding during various types of surgery; the 

Axis Implant is used to augment or reconstruct the chin. Id. Inspections performed by the 

Food and Drug Administration (FDA) prior to the filing of the 1999 Complaint revealed that 

defendants had failed, over a period of several years, to assure that the Electro Probe and 

Axis Implant were manufactured in conformity with FDA's current good manufacturing practice 

(CGMP) regulations -- regulations promulgated to assure that devices are safe and effective. 

See 21 U.S.C. § 360j(f) (1) and 21 C.F.R. Part 820.

3. The Decree permanently enjoined defendants Firm A and Individual A and any and 

all of their representatives, agents, employees, successors, and those persons in active 

concert or participation with any of them who received actual notice of the contents of the 

Decree from "directly or indirectly"

(1) introducing or causing to be introduced into interstate commerce, or delivering or 

causing to be delivered for introduction into interstate commerce, any article of device 

within the meaning of 21 U.S.C. § 321(h); and

(2) manufacturing, packing, or storing any article of device held for sale ... unless and 

until:

A. The methods used in, and the facilities and controls used for and by 

defendants for manufacturing, packing, or storing devices comply with the Food 

and Drug Administration's (FDA) good manufacturing practice (GMP) 

regulations for devices.

Ex. 2 ¶ I11 (emphasis added).

4. The Decree set forth conditions under which the defendants could resume 

operations. See Ex. 2 ¶ I11 B-E. Those bound by the Decree could begin shipment of devices 

in interstate commerce only after:

a. defendants hired an expert consultant to inspect Firm A’s manufacturing, 

packing, and storing systems;

b. defendants certified to FDA that, based upon such inspection, the consultant 

had concluded that Firm A could in the future manufacture devices in conformity with 

FDA’s CGMP regulations;

c. FDA made such inspections as it deems necessary; and

d. FDA gave defendants written authorization to begin manufacturing and 

distributing devices. Ex. 2 ¶ III B - E.
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5. Approximately one year after the Decree was entered, Firm A certified to FDA that it 

could manufacture and distribute the Axis Implant in conformity with the law, and FDA 

provided Firm A written authorization to so do. Ex. 3. FDA did not authorize, and to date has 

not authorized, the manufacture and delivery of any other Firm A devices, including the Electro 

Probe.

DEFENDANTS HAD ACTUAL NOTICE OF THE DECREE

6. At the time the 1999 Complaint was filed, defendant Individual A was the President 

of Firm A and signed the Decree both on behalf of Firm A as its president as well as in his 

capacity as an individual defendant. Ex. 2 at 10. Upon the Decree's entry, defendant 

Individual B became Firm A’s President, Ex. 4, and he signed a statement dated May 19, 

1999, acknowledging receipt of the Decree. Ex. 5.

7. Defendant Individual C was a Firm A employee when the Decree was entered. Id. 

Firm A sent a copy to her by certified mail pursuant to Paragraph IX of the Decree, which 

required that Firm A provide copies of the Decree to all its officers and employees. Ex. 2 ¶ IX. 

She signed for receipt of the Decree on May 25, 1999. Ex. 5.

8. Individual D was also a Firm A employee when the Decree was entered. Id. He 

signed a statement dated May 19, 1999, stating that he had received a copy of the Decree 

from Firm A. See Ex. 5.

9. Soon after agreeing to and receiving notice of the Decree, Firm A and Individual B 

entered into negotiations with FDA to allow Firm A to export at least some of its inventory of 

pre-Decree devices to Europe under a provision in the Decree that allowed defendants to 

attempt to bring the devices into compliance with the law. Ex. 6. FDA worked with Firm A and 

Individual B to assure that any such export complied with the FDCA. Id. and Ex. 7. On 

October 19, 1999, this effort culminated in Firm A exporting its pre-Decree inventory to Med 

Dev Europe, an affiliate of Firm A’s located in the Netherlands, which later distributed the 

devices to a company called Device Workshop, also in the Netherlands. Ex. 8.

10. Defendant Individual E was the director of Device Workshop and, therefore, a 

customer of Firm A’s. To lawfully ship adulterated devices to Device Workshop, Firm A had to 

establish, among other things, that the devices accorded to Device Workshop's specifications. 

See 21 U.S.C. § 381(e) (1) (A). To do so, FDA suggested that Firm A inform Individual E that 

the devices he would receive had not been manufactured in conformity with CGMP. See Ex. 

6, June 26, 1999, letter to Mark Able from FDA, at 3. Firm A did so and, on October 2, 2000, 

Individual E sent a letter to Firm A stating that he had read and understood the Decree. Ex. 9.

11. During the negotiations between Firm A and FDA over the circumstances of export 

of its inventory, Firm A requested permission to distribute in the United States components of 

some of its devices, including the Electro Probe. Ex. 7, July 24, 1999, letter to FDA from 

Michael Smith. FDA advised Firm A in writing that manufacturing, holding for sale, or selling in 

interstate commerce components of its devices would constitute a violation of the Decree 

because the components were devices that had not been brought into compliance with 

CGMP, as required by the Decree. Ex. 7; see also 21 U.S.C. § 321(h).

THE DEFENDANTS' VIOLATIONS OF THE DECREE

12. Despite FDA's efforts to work closely with Firm A to effect a lawful export of its 

inventory, Firm A's certification to FDA that the Axis Implant could be manufactured and 
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distributed in compliance with the CGMP regulations, and FDA's notice to Firm A that the 

unauthorized manufacture and distribution of device components would be a violation of the 

Decree, defendants flagrantly violated the Decree's requirements with respect to the Electro 

Probe. As shown below, the individual defendants violated the requirements of the Decree by 

establishing a successor corporation to Firm A called Firm B, transferring assets and 

employees to Firm B, and manufacturing and distributing components of the Electro Probe to 

Med Dev Europe. These components could be easily assembled by purchasers to form a 

finished Electro Probe device.

Defendant Firm A

13. Between entry of the decree on April 25, 1999, and at least until the beginning of 

an FDA inspection of Firm B on September 3, 2000, defendant Firm A caused the manufacture 

and distribution of the Electro Probe through defendants Firm B, Individual B, Individual C, and 

Individual D despite the fact that FDA had not authorized the manufacture and distribution in 

interstate commerce of the Electro Probe, as is required by the Decree. Ex. 2 ¶ 111. Firm A 

provided to Firm B critical business assets -- the plans and specifications for the Electro Probe, 

Ex. 10, and a list of its suppliers. Ex. 11. Firm B labeled the Electro Probes it manufactured to 

state that they had been manufactured by Firm A. Ex. 12. Firm A employees Individual C and 

Individual D worked for Firm B for several months while also on the Firm A payroll. Ex. 13 ¶¶ 4 

and 5. And, Firm A’s president directed Individual C and Individual D in the performance of 

their duties while they were employed by Firm B. Id. In short, Firm A knowingly and 

deliberately violated the terms of the Decree by causing Firm B to manufacture and introduce 

into interstate commerce components for the Electro Probe, even though FDA had not 

authorized such activities.

Defendant Firm B

14. On or about November 13, 1999, six months after entry of the Decree, 

defendants Individual A, Individual B, and Individual E filed papers incorporating Firm B in the 

Commonwealth of Virginia for the stated purpose of "servicing of electrosurgical or related 

medical devices" and "any activity reasonably incidental or reasonably necessary thereto." Ex. 

14, Articles of Incorporation, 1. Defendant Individual E is the president of Firm B and 

defendants Individual A and Individual B serve as directors of that firm. Id. at 6 Defendant 

Individual A, a named defendant in the Decree, owns eighty percent of Firm B’s stock. Id. at 8-

10. Individual B and Individual E own the remainder of the stock. Id. at 8- 10.

15. Between November of 1999 and September of 2000, Firm B manufactured and 

distributed devices intended for reconstruction of the nose and chin. Specifically, defendant 

Firm B:

a. Employed former Firm A employees Individual C and Individual D as vice 

presidents. Ex. 13 ¶¶ 4 and 5.

b. Received from defendants Individual B and Firm A specifications and plans to 

manufacture Firm A’s devices, including the Electro Probe. These plans were labeled 

"Medical Device Research Partners" or "Firm A, Inc.," indicating that they were 

developed for use by Firm A and were the business assets of Firm A. See Ex. 10. As a 

result, Firm B received a significant business asset from Firm A and is a successor 

corporation to Firm A. As a successor corporation, Firm B is bound by the Decree. Ex. 

2 ¶ 111.
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c. Ordered Electro Probe parts identical to those previously ordered by Firm A 

from the same companies that had supplied Firm A. Some of these parts were ordered 

from companies outside of Virginia. Id. As a result, Firm B stored devices after 

shipment of one or more of their components in interstate commerce.

d. Used these parts to manufacture device components which could be 

assembled into devices identical to those manufactured by Firm A, including the Electro 

Probe. Ex. 13 ¶ 5. Such manufacture is expressly prohibited by the Decree. Ex. 2 ¶ III 

(2).

e. Labeled at least some of the finished device components "Firm A, Inc. 

Richmond, VA USA," although they had been manufactured by Firm B. Ex. 12. Such 

manufacture and distribution in interstate commerce are in direct contravention of the 

Decree's prohibitions. Ex. 2 ¶ III(1) and (2).

f. Stored the device components in Firm B’s facility at Richmond, Virginia. Such 

storing is expressly prohibited by the Decree until such time as FDA authorizes storing 

devices by Firm A or others bound by the Decree. Id.

g. Delivered these device components to Highland International Forwarders for 

shipment to Med Dev Europe in the Netherlands, and then submitted invoices to Med 

Dev Europe for the device components. Ex. 15. Such distribution is expressly 

prohibited by the Decree until such time as FDA authorizes distribution in interstate 

commerce. Compare Ex. 2 ¶ III(1) with ¶ III E.

16. Firm B only manufactured and distributed device components that were 

previously manufactured and distributed by Firm A; it did not manufacture any other products.

17. During FDA’s inspection, Firm B employees claimed that they were merely 

manufacturing components of devices. Ex. 13 ¶¶ 4 and 5. By law, components of devices are 

also devices, 21 U.S.C. § 321(h). Moreover, records indicate that Firm B shipped to 

customers the same number of components in each shipment that could easily be assembled 

to complete finished devices identical to Firm A‘s Electro Probe. Ex. 13 ¶¶ 5 and 9; Ex. 15. 

These components were ordered by “Individual B” at Med Dev Europe. See Ex. 15 at 2. FDA 

collected records at Firm B which show that Firm B shipped components for the assembly of at 

least 59 finished devices. Ex. 13 ¶ 6.

Defendant Individual A

18. Defendant Individual A signed the Decree both in his capacity as the president of 

Firm A and as an individual defendant. Ex. 2 at 10. He had direct and actual knowledge of the 

Decree’s contents. See. Nevertheless, just seven months after signing the Decree, he agreed 

to serve as a member of the Board of directors of Firm B and purchased eighty percent of Firm 

B’s stock, see Ex. 14, and while so serving, he manufactured device components consisting of 

one or more components that had been shipped in interstate commerce and, later, introduced 

the device components into interstate commerce. Such actions were in direct violation of the 

Decree because the Decree specifically prohibited Individual A’s manufacture and distribution 

in interstate commerce of the Electro Probe unless and until FDA authorized such work. Ex. 2 

¶ III (l), (2), and E. To date, FDA has not so authorized.
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Defendant Individual B

19. Defendant Individual B was the vice president of Firm A in 1998 and became its 

president in March 1999. Ex. 4. He signed a statement on May 19, 1999, acknowledging 

receipt of a copy of the Decree from Firm A. Ex. 5. Individual B also corresponded extensively 

with FDA after entry of the Decree, see Ex. 6, and certified to FDA that Firm A’s Axis Implant 

manufacturing line was operating in compliance with the CGMP regulations. Ex. 3. In short, 

Individual B continually demonstrated that he understood the provisions of the Decree and 

Firm A’s obligations under that Decree.

20. Despite the Decree's restrictions and Individual B’s understanding of them, 

Individual B violated the Decree in several ways. First, Individual B served as a member of 

Firm B’s Board of Directors. Ex. 14. Second, Individual B directed the contumacious activities 

of defendants Individual C and Individual D while they were employees at Firm A and, later, at 

Firm B. Ex. 13 ¶¶ 4 and 5. Third, Individual B delivered to Firm B the plans and specifications 

for Firm A’s Electro Probe so that Firm B could manufacture the device components and ship 

sets of them to Med Dev Europe. Id. ¶ 4. Fourth, after FDA's inspection revealed to FDA that 

defendants were manufacturing and distributing components for Firm A’s Electro Probe, 

Individual B wrote to defendant Individual C and stated that Med Dev Europe would not 

provide the money necessary to bring Firm B into compliance with CGMP, Ex. 16, as is 

expressly required by the Decree. Ex. 2 ¶ 111 A - E. Individual B resigned as president of 

Firm A soon after FDA's inspection of Firm B. Ex. 17.

21. Defendant Individual B’s activities were in direct contravention of the Decree 

because he actively participated in a scheme to circumvent the requirements of the Decree 

through the manufacture and distribution of Firm A’s Electro Probe despite the fact that the 

defendants had not certified to FDA that they could manufacture and distribute the Electro 

Probe in compliance with CGMP regulations and FDA had not authorized such activities.

Defendant Individual C

22. Defendant Individual C was an employee of Firm A at the time the Decree was 

entered by this Court. Ex. 18. She received notification of the Decree through certified mail by 

Firm A, Ex. 5, and was bound by its terms. Ex. 2 ¶ 111.

23. Despite the provisions of the Decree, while she was employed at Firm A, 

Individual C also worked for Firm B during evenings and weekends to help establish the 

company. Ex. 13 ¶ 4. She admitted doing so in order to assist defendant Individual B in his 

effort to supply Med Dev Europe with device components so that at least some of Firm A’s 

devices could be sold overseas. Id. On March 29, 2000, Individual C began working full time 

for Firm B. Ex. 13 ¶ 4 and Ex. 18.

24. At Firm B, defendant Individual B was a vice president in charge of administrative 

matters. Ex. 13 ¶ 4. She was responsible for ordering and receiving parts, preparing invoices, 

and shipping devices to Med Dev Europe. See Ex. 15. She told FDA investigators that, while 

defendant Individual B was responsible for some managerial decisions at Firm B, she also 

made managerial decisions for the company. Ex. 13 ¶ 4. Individual C also carried out 

Individual B’s instructions when necessary. Id.

25. Once FDA's inspection of Firm B was completed, Individual C requested financial 

support from Individual B to enable Firm B to come into compliance with CGMP, Ex. 16, 
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revealing Individual C’s understanding that Firm B was required to comply with CGMP 

regulations.

Individual D

26. Defendant Individual D was an employee of Firm A at the time the Decree was 

entered by this Court. Ex. 18. He was notified of it by Firm A, Ex. 5, and was bound by its 

terms. Ex. 2 ¶ 111. Like Individual C, while employed at Firm A, he worked evenings and 

weekends to set up Firm B and later went to work for Firm B full time. Ex. 13 ¶ 5.

27. Individual D was Firm B’s vice president for production. Id. He was responsible 

for producing all device components that Firm B manufactured, packed, and stored. Id. 

Individual D told FDA investigators that he produced approximately 100 to 200 subassemblies, 

or components, of devices according to training and device specifications that he received 

from defendant Individual B. Id. When questioned by FDA investigators about the similarity in 

the names for Firm B’s and Firm A’s electrosurgical devices (Firm A’s Electro Probe is called 

the ER-8100 and Firm B’s is called the ESU- 8100), Individual D acknowledged that they were 

the same device. Id.

28. The Decree prohibited Firm A, its employees, and all persons in active concert or 

participation with either of them, which language clearly includes Individual D, from 

manufacturing, packing, storing, and distributing all devices, including the Electro Probe, until 

FDA authorized such activities. Despite this clear prohibition, Individual C continued to 

oversee manufacture, packing, storage, and distribution of a device that had changed in name 

only. This is a clear violation of the Decree.

Individual E

29. By letter dated October 2, 1999, Individual E acknowledged that he knew of and 

understood the terms of the Decree. Ex. 6. Yet, in November of 1999, he began serving as 

the president of Firm B. With the help of Individual C and Individual D in 2000, he 

manufactured the Electro Probe, stored it, and introduced it into interstate commerce. All of 

these acts were in direct violation of the Decree's prohibitions of the manufacture and 

distribution in interstate commerce of devices that FDA had not, and has not, authorized in 

writing.

WHEREFORE, pursuant to Rule 42(b) of the Federal Rules of Criminal Procedure, the 

United States of America respectfully requests that this Court:

1. Issue an Order to Show Cause requiring defendants Firm A and Firm B, 

corporations, and Individual A, Individual B, Individual C, Individual D, and Individual E, 

individuals, to appear before this Court and to show cause why they should not be adjudged in 

criminal contempt of the Decree entered by this Court on April 25, 1999;

2. Following the issuance of the Order to Show Cause and an appropriate hearing, 

enter a judgment of criminal contempt against defendants Firm A and Firm B, corporations, 

and Individual A, Individual B, Individual C, Individual D, and Individual E, individuals, for 

violating the April 25, 1999 Decree;

3. Impose an appropriate fine against the defendant Firm B;

4. Impose an appropriate fine against the defendant Firm A.;
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5. Impose an appropriate fine or term of imprisonment against the individual defendant 

Individual A;

6. Impose an appropriate fine or term of imprisonment against the individual defendant 

Individual B;

7. Impose an appropriate fine or term of imprisonment against the individual defendant 

Individual C;

8. Impose an appropriate fine or term of imprisonment against the individual defendant 

Individual D;

9. Impose an appropriate fine or term of imprisonment against the individual defendant 

Individual E; and

10. Grant such other relief as the Court deems just and proper.

Dated:______________

Respectfully submitted:

NAME IN CAPS

Assistant Attorney General

NAME IN CAPS NAME IN CAPS

Chief Counsel United States Attorney

NAME IN CAPS _____________________

Associate Chief Counsel

Food and Drug Administration Assistant U.S. Attorney

5600 Fishers Lane Address

Rockville, MD 20857 City, State Zip

301-827- _____ Phone number

_____________________

Office of Consumer Litigation 

Department of Justice

P.O. Box 386

Washington, D.C. 20044
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Exhibit 6-23

ORDER TO SHOW CAUSE

UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF _________

UNITED STATES OF AMERICA, )

Plaintiff,

)

)

v. ) Criminal Action No.______

)

NAME IN CAPS

)

and

)

NAME IN CAPS.

)

Corporations

)

)

and )

NAME IN CAPS, )

NAME IN CAPS, )

NAME IN CAPS, )

NAME IN CAPS, )

and )

NAME IN CAPS, )

Individuals, )

Defendants )

ORDER TO SHOW CAUSE

Upon consideration of the government’s Petition for an Order to Show Cause why the 

defendants Firm A, Inc. (Firm A), Firm B, Inc. (Firm B), corporations, and, Individual A, 

Individual B, Individual C, Individual D, and Individual E, individuals, should not be held in 

criminal contempt, and it appearing to the Court from the allegations contained therein that the 

defendants have violated the terms of the Consent Decree of Permanent Injunction entered on 

April 25, 1999, it is therefore:

ORDERED, pursuant to Rule 42(b) of the Federal Rules of Criminal Procedure, that 

defendants Individual A, Individual B, Individual C, Individual D, and Individual E, and duly 

authorized representatives of defendants Firm A and Firm B shall appear before this Court in 

Room No. __ , ___________ (address), City, State on______(date) at (time), and 

show cause why they should not be held in criminal contempt of the permanent

injunction entered in the above-captioned case on April 25, 1999.
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SO ORDERED:

Dated: __________, 2001.

___________________________

Judge 

United States District Judge
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Exhibit 6-24

FORMAT FOR PROSECUTION SUMMARY AND RECOMMENDATION

Memorandum

FROM:_______________________ District/Division/Program ________________

SUBJECT: PROSECUTION

Lead Sample Number, et al.

TO: Division of Enforcement, Office of Enforcement and Import Operations or

Center for Drug Evaluation and Research, Office of Compliance (HFD-300) or

Center for Food Safety and Applied Nutrition, Office of Compliance (HFS-600) or

Center for Veterinary Medicine, Office of Surveillance and Compliance (HFV-200) or

Center for Devices and Radiological Health, Office of Compliance (HFZ-300) or

Center for Biologics Evaluation and Research, Office of Compliance and Biologics Quality 

(HFM-600)

SAMPLE NO., PRODUCT, DATE SHIPPED, AND RELATED INFORMATION

In a case where an element of the offense does not involve samples, outline the elements 

which describe the offense.

CITATION

LEGAL STATUS

ALLEGED VIOLATION

HISTORY

PRIOR NOTICE

OTHER CORRESPONDENCE

WITNESSES FOR INSPECTIONAL AND ANALYTICAL FINDINGS

OTHER WITNESSES

RECOMMENDATION

PERMANENT ABEYANCE OF SAMPLES AND/OR INDIVIDUALS

SAMPLE DATA

1. Date Lot Shipped/Received
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2. Date Lot Sampled/By

3. Description of Lot and Sample Size

4. Analysts

5. Analytical Method(s)

6. Number of Subs Analyzed

7. Analytical Findings verifying that part of offense based on laboratory analysis

8. 702(b) portion

9. Seizure(s)

10.Recall(s)

11.Documentation of Interstate Commerce

REMARKS

Signature of Compliance Officer

Signature of Director, Compliance Branch

Concurrence by: District/Division/Program Director(s)

Enclosures:

Case files
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Exhibit 6-25

MODEL PROSECUTION SUMMARY AND RECOMMENDATION MEMORANDUM

DATE:

FROM: District/Division/Program_________________

SUBJECT: PROSECUTION

Lead Sample Number, et al.

TO: Division of Enforcement, Office of Enforcement and Import Operations

2.SAMPLE NO. 3.PRODUCT 4.DATE 

SHIPPED

5.RELATED INFORMATION

6.Sample No. 7.Lima Beans 8.12/18/01 9.Seized 

10.(Count I) 11. 12. 13.

14.Sample No. 15.Lima Beans 16.11/20/01 17.Seized 

18.(Count II) 19. 20. 21.

22.Sample No. 23.Peas 24.11/31/02 25.Vol. destroyed 

26.(Count III) 27. 28. 29.

30.Sample No. 31.Lima Beans 32.11/30/02 33.Seized 

34.(Count IV) 35. 36. 37.

CITATION

Issued to: Firm

Street Address

City, State Zip

a corporation

and

Individual A, President

Street Address

City, State Zip

and

Individual B

Street Address

City, State Zip

Individuals
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There has been no new evidence developed since the Recommendation for Citation was 

submitted or at the 305 meeting on [date]. Therefore, the case was sent directly to the 

Division of Enforcement.

LEGAL STATUS

Firm, Inc. was incorporated under the laws of the State of in 1978. 

Certified copies of the Articles of Incorporation have been obtained. The officers of the 

corporation are Individual A, President and Chief Executive Officer, and Individual B, 

Warehouse Distribution Manager. The responsible individuals at the Irving warehouse are the 

same now as at the times of violations.

ALLEGED VIOLATIONS

This storage warehouse has been storing peas and beans which have become rodent 

contaminated after receipt in interstate commerce. 21 U.S.C. 331(k), 342(a)(3), and (4). Lima 

beans represented by samples collected during the inspection of , are 

adulterated within the meaning of 21 U.S.C. 342(a)(3) in that the products contained rodent 

excreta pellets and live insects (Count I) and rodent hairs (Count II). Peas and lima beans are 

represented by samples collected during the inspection of ______________, and are 

adulterated within the meaning of 21 U.S.C. 342(a)(3) in that the peas contained rodent 

excreta and rodent hairs (Count III) and the beans contained live insects (Count IV).

In addition, the products were adulterated within the meaning of 21 U.S.C. 342(a)(4) because 

they were held under conditions which could have resulted in their becoming contaminated 

with filth (Counts I-IV).

HISTORY

The proposed defendants have a long history of noncompliance with the Food, Drug, and 

Cosmetic Act. FDA first inspected the firm in February 1993. That inspection revealed 

widespread rodent and insect infestation. Products found in violation were voluntarily 

destroyed. Inspection in 1994 revealed continuing problems and two lots of rice were seized, 

No. , N.D. Texas (FDA reference FDC ). Between 

1995 and 2000, FDA and State of Texas, under contract with the FDA, inspected the 

Corporation on several occasions. Those inspections revealed some minor insanitary 

conditions and resulted in the voluntary destruction of some foods.

In June 2001, a joint inspection by FDA and the state again revealed extensive rodent 

infestation. No food was seized as Individual A voluntarily destroyed the contaminated lots. 

Follow-up inspections in May 2002 and December 2002 are the subject inspections upon 

which this recommendation is based.
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PRIOR NOTICE

After each of the referenced inspections management at the Irving warehouse received a Form 

FDA 483 Inspectional Observations (FDA 483). Seizures of food products were accomplished 

in 1994, 2001, and 2002. A Warning Letter was issued to the Corporation and Individual A on 

October 25, 2001.

OTHER CORRESPONDENCE

Attached are copies of correspondence between the state and the corporation covering the 

period from 1995 to the present time.

WITNESSES FOR INSPECTIONAL AND ANALYTICAL FINDINGS

SAMPLE NO. COLLECTING INVESTIGATOR

ANALYST

(COUNT I) (Name)

(Name)

(COUNT II) (Name)

(Name)

(COUNT III) (Name)

(Name)

(COUNT IV) (Name)

(Name)

All investigators and analysts are presently located at the [ORA Division/Program] office.

OTHER WITNESSES

Name, address, phone number, title - An expert on rodent and insect contamination of storage 

products.

RECOMMENDATION

Prosecution of: Firm, Inc. (All Sample Nos.)

and

Individual A, and

Individual B

(all defendants on each sample)

The proposed defendants have received prior warning during inspections, FDA 483s, Warning 

Letter, and accomplished seizures.
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PERMANENT ABEYANCE OF SAMPLES AND/OR INDIVIDUALS

Above named corporation (Sample No.) and individuals (Sample No.). We have 

recommended permanent abeyance of these two numbers only to restrict the proposed 

information to four counts per wishes of the local District Court.

SAMPLE DATA

COUNT I

38. 39.Sample No. - Lima Beans

40.Date Lot Received: 41.1-27-2002

42.Date Lot Sampled/By: 43.5-9-2002 by (Name) ( ORA 

Division/Program)

44.Description of Lot

45.and Sample Size:

46.Lot - 42 bales (12/2 lb. bags); 13 bales were examined, 6 

had rodent excreta and 3 had rodent urine on their surfaces, 8 

were rodent gnawed and in 5 bales the gnawing penetrated 

cello bags inside the bales. Cello bags in one bale contained 

insects and one cello bag was almost completely empty and 

contained rodent excreta. A nest containing three dead 

rodents was found between bales in the lot. An 11 sub 

selective sample consisting of 7 rodent gnawed cello bags 

collected from 5 different bales and 4 subs from the exterior of 

bales was collected

47.Analyst: 48.Name ( - ORA District/Division/Program)

49.Analytical Methods: 50.Macroscopic, Microscopic, and Xanthydrol

51.Number of Subs 

Analyzed:

52.All

53.Analytical Findings: 54.402(a)(3) Verification

55.Subs IB, 3, 3A, 4, 5, and 5A. poly bags of beans bearing 

rodent incisor marks penetrating bagging material. Sub 3A 

contained a fly. Sub 3 contained an insect pupa case. Subs 3A 

and 5 contained insect pupae. Subs 4 and 5A contained rodent 

excreta pellets.

56.402(a)(4) Verification

57.Other subs collected from exterior of lot revealed gnawed 

bagging material, urine stained paper, and rodent hairs.

58.702(b) Portion: 59.Yes

60.Seizure: 61.Yes

Documentation of Interstate Commerce:
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1. Dealer's Statement dated 5-09-2002 signed by Mr. , as General Foreman 

(Assistant Distribution Manager), Firm, Inc., City, State covering receipt of the lot on or about 

1-27-2002 from Food Products, Inc., Dallas, Texas, and sampling.

Mr. furnished copies of the following documents:

a. Firm, Inc. Purchase Order No. 0123 dated 1-18-2002 stamped "Hauled on Rogers 

truck" and marked "Date Received 1-27-2002."

b. Invoice No. 76543 dated 1/27/2002 issued by Food Products, Inc.

2. Affidavit dated 5/19/2002 signed by Mr. , Quality Assurance 

Manager, Food Products, Inc., Dallas, Texas, stating that the shipment of lima beans to Firm, 

Inc., City, State, under Invoice No. 7653 dated 1/27/2002, was packed by his firm from beans 

received from Downs Warehouse Company, Crows Landing, California. Mr. furnished 

copies of the following documents:

a. Invoice No. 010305 dated 12/28/2001 issued by Downs Warehouse Co.

b. Bill of Lading (Shipper's No. 5520 and Agent's No. 43218) dated 12/28/2001 issued 

by Southern Pacific Transportation Company, covering the shipment of 194,000 pounds 

of dry beans from Downs Warehouse Company, Crows Landing, California, to Food 

Products, Inc., Dallas, Texas.

(Counts II through IV of this example would be listed with the factual information as in Count I 

above.)

REMARKS

We are not aware of any potential problem areas or weaknesses in the case. Individual A is in 

his mid-40's, while Individual B is reportedly 38.

OCI was contacted regarding the case and declined it.
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Prosecution is the action of choice in this case. The evidence shows that this firm, under 

current management, had serious rodent and insect infestations as early as 1993, and despite 

repeated warnings, has allowed these grossly filthy conditions to persist.

Signature of Compliance Officer

Signature of Director, Compliance Branch

Concurrence by: District/Division/Program Director(s)

Enclosures:

cc: Notice of Hearing and Charge Sheet

cc: Record of Hearing and Hearing Exhibits

cc: Legal Status Sheet

cc: Articles of Incorporation

cc: Collection Reports, Labels, Worksheets, and state correspondence (5)

In separate envelope:

3 cys. Notice of Hearing and Charge Sheet

1 cy. Articles of Incorporation

3 cys. letter to firm dated 10-25-87

cc: HFS-605

HFA-224
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Exhibit 6-26

MODEL LETTER REQUEST FOR ARTICLES OF INCORPORATION

Dear Sir:

Re: Name of Firm

Address of Firm

Please furnish us with copies of the Articles of Incorporation and Certificate of 

Existence for the referenced firm. As these documents may be introduced as evidence 

in a court proceeding in accordance with Rule 44 of the Federal Rules of Civil 

Procedure (copy enclosed), it will be necessary for them to be authenticated by the 

officer having legal custody of these records, or by his deputy, and accompanied by a 

certificate that the individual is legal custodian of these records.

The documents should cover the existence of the firm for the period from on or about 

(earliest shipment date contained in the Information or Indictment) to the present time.

Sincerely,
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Exhibit 6-27

RULE 44 – PROVING AN OFFICIAL RECORD

To establish that a document, or an entry in it, to be used as evidence is an official record 

that is otherwise admissible:

See the Federal Rules of Civil Procedure at 28 USC § 44 – Proving an Official Record 

on www.gpo.gov.

(From the Federal Rules of Civil Procedure. Incorporates the revisions that took effect January 

7, 2001.)
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Exhibit 6-28

Rule 6. THE GRAND JURY

See the Federal Rules of Criminal Procedure at 28 USC § 44 – Proving an Official Record at 

www.uscourts.gov > Rules of Criminal Procedure.

(From the Federal Rules of Criminal Procedure. Includes text from 2011, 2014 amendments.)
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Exhibit 6-29

EXAMPLE OF LETTER TO THE DEPARTMENT OF JUSTICE, RE: INJUNCTION AND CIVIL 

PENALTY

Office of the Chief Counsel

Food and Drug Administration

5600 Fishers Lane, GCF-1

Rockville, Maryland 20857

Our Ref: INJ [insert number] [insert date]

[insert name], Director

Office of Consumer Litigation

Civil Division

Department of Justice

Post Office Box 386

Washington, D.C. 20044

Dear [insert name]:

Investigations conducted by the Food and Drug Administration (FDA) indicate that ABC 

Company, Inc. (ABC) and Alan R. Smith, its president, have violated the Federal Food, Drug, 

and Cosmetic Act (the Act), 21 U.S.C. 301, et seq. Specifically, ABC and Alan R. Smith have: 

(1) manufactured and distributed into commerce 149 diagnostic x-ray systems which did not 

comply with the applicable performance standards prescribed in the Act, in violation of 21 

U.S.C. 360oo(a)(1); (2) issued 22 certifications that 22 x-ray systems complied with the 

applicable performance standards, when they had knowledge that the certifications were false 

or misleading in a material respect, in violation of 21 U.S.C. 360oo(a)(5)(B); and (3) failed to 

notify the purchasers of 270 x-ray units that the units did not comply with the applicable 

performance standards, and failed to bring the 270 x-ray units into compliance with the 

standards, without charge, or to replace the x-ray units with like or equivalent x-ray units, or to 

refund the cost of the units, all in violation of 21 U.S.C. 360oo(a)(2). Therefore, we request the 

initiation of an action for permanent injunction and civil penalties against both the corporate 

and individual defendants.

A. BACKGROUND

ABC is a corporation organized under the laws of the State of Illinois, with headquarters in 

Peoria, Illinois, and trading and doing business in the State of Illinois. The firm became 

incorporated on March 23, 1967. Alan R. Smith has been President and Chief Executive 

Officer of the firm since 1989. He also holds the position of Corporate Treasurer. Prior to 1989, 

Alan R. Smith was the firm’s Vice President. In his current position, Alan R. Smith is 

responsible for ABC’s importation, production, sales, and complaint handling operations. ABC

is engaged in the importation and manufacture of diagnostic x-ray systems. Since 1976, ABC 

has imported two basic x-ray units, models 11 and 12, from X-Ray Company in Japan. ABC 
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manufactures these x-ray units for use as portable, general purpose systems or as mobile, 

wall-mounted, or stationary podiatry systems.1

Models 13, 14, 15, and 16 (mobile and wall-mounted podiatry x-ray systems), and models 17, 

and 18 (portable, general purpose x-ray systems), are the products at issue in the proposed 

injunction and civil penalties action.

B. APPLICABLE LAW

The Electronic Product Radiation Control Program (the Program), 21 U.S.C. 360hh - 360ss, is 

part of the Federal Food, Drug, and Cosmetic Act. Congress intended the Program to protect 

the public from the hazard of unnecessary exposure to radiation emitted by electronic products 

such as diagnostic x-ray systems. To achieve this end, the Program proscribes a manufacturer 

from introducing into commerce any electronic product that does not comply with the 

applicable standards promulgated by the Commissioner of Food and Drugs under authority 

delegated to him by the Secretary of Health and Human Services ("Secretary") under 21 CFR 

5.10(a)(3). 21 U.S.C. 360oo(a)(1).

The standards promulgated by the Commissioner include a light localizer illuminance 

requirement, 21 CFR 1020.31(d)(2)(ii), and a contrast ratio requirement, 21 CFR 

1020.31(d)(2)(iii). X-ray systems use a light localizer to define the light field so the operator of 

the equipment can adjust the x-ray field to the proper image receptor size. The contrast ratio 

requirement exists to permit the operator to align the film with the edges of the x-ray field. 

Failure of a system to meet these two requirements could cause the operator to visualize 

inaccurately the x-ray field, and could result in an x-ray field that is larger than necessary for 

the examination. An x-ray field that is too large or misaligned could overexpose the patient to 

radiation, and could unnecessarily expose sensitive body organs to radiation. If critical organs 

are exposed to radiation, there is an increased risk to the patient of cell damage and cancer.

ABC and Alan R. Smith, as importers of diagnostic x-ray equipment and manufacturers of 

complete diagnostic x-ray systems, are "manufacturers" within the meaning of 21 U.S.C. 

360hh(3) and 21 CFR 1000.3(n).

In addition to prohibiting manufacturers from placing noncompliant products into commerce, 

the Program also requires that manufacturers certify that their products meet the applicable 

standards. 21 U.S.C. 360kk(h). The Program prohibits a manufacturer from certifying that a 

product complies with the applicable performance standards when the manufacturer, in the 

exercise of due care, would have reason to know that the certification is false or misleading in 

a material respect. 21 U.S.C. 360oo(a)(5)(B). Furthermore, the Program requires that 

manufacturers notify the users of equipment that it does not meet the performance standards 

and correct those systems that are violative. 21 U.S.C. 360oo(a)(2). Specifically, the 

manufacturers must notify promptly the Secretary and the dealers, distributors, and/or first 

1 ABC's models 11 and 12 x-ray systems are each made up of two different components. One component is 

comprised of a tube housing assembly, a high voltage generator, and an x-ray control. The second component, a 

collimator, is a beam-limiting device that provides a means to restrict the dimensions of the x-ray field. ABC has 

equipped both the models 11 and 12 x-ray systems with model 19 collimators. The only difference between the 

model 11 and 12 systems is that model 11 has a fixed output tubehead and model 12 has a variable output 

tubehead. The components of the systems are otherwise identical.

ABC's podiatry x-ray systems are designated as follows: stationary: models 20 and 21; mobile: models 13 and 14; 

and wall-mounted: models 15 and 16. ABC's portable, general purpose x-ray systems are designated as models 

17 and 18.
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purchasers of any electronic products that have a defect or that do not comply with any 

applicable performance standard. 21 U.S.C. 360ll(f). Manufacturers must also bring the 

violative product into compliance with the standards, without charge, or replace the product 

with a like or equivalent product that meets the standards, or refund the cost of the product. 21 

U.S.C. 360ll(f).

A manufacturer who violates any of the provisions described above is subject to civil penalties 

of not more than $1,000 per violation, up to a total of $300,000 for any related series of 

violations. 21 U.S.C. 360pp(b)(1).

C. CHARGES AND SUPPORTING EVIDENCE

The attached complaint charges each defendant with 149 violations of 21 U.S.C. 360oo(a)(l), 

introducing into commerce electronic products that do not comply with the applicable 

standards. The complaint also charges each defendant with 22 violations of section 

360oo(a)(5)(B), issuing 22 certifications that 22 x-ray products complied with the applicable 

performance standards, when, in the exercise of due care, they should have known that the 

certifications were false or misleading in a material respect. Finally, the complaint charges 

each defendant with 270 violations of 21 U.S.C. 360oo(a)(2), failing to notify users that the 

equipment was violative and failing to bring the equipment into compliance, without charge, or 

replace the violative equipment, or refund the cost of the equipment.

The employee from FDA’s Winchester Engineering and Analytical Center (WEAC) who tested 

the defendants’ x-ray system will testify that the defendants’ mobile and wall-mounted podiatry 

x-ray systems and their portable, general purpose x-ray systems do not comply with the light 

illuminance, contrast ratio, and labeling and certification requirements, 21 CFR 

1020.31(d)(2)(ii) and (iii) and 21 CFR 1010.2, respectively. A witness from the Center for 

Devices and Radiological Health (CDRH) will be available to provide expert testimony 

concerning the diagnostic x-ray standards and the health risks associated with x-ray systems 

that fail to meet the performance standards.

FDA investigators who conducted the inspections at ABC will testify that the defendants placed 

into commerce a total of 149 violative x-ray units between January 18, 1991 and August 8, 

1995. The investigators will also testify that defendants sold 22 of these units, with certification, 

after they had knowledge that the units did not comply with the regulations. In addition, the 

investigators will produce evidence documenting that the defendants sold a total of 270 

noncompliant units from January 21, 1988 through August 8, 1995. The defendants did not 

notify the users of the 270 x-ray systems about the violations, nor did the defendants take 

action to correct the violations.

D. DEFENDANTS’ VIOLATIVE CONDUCT

1. The Initial Warning Letter and Follow-Up Correspondence

On August 9, 1993, CDRH issued a Warning Letter to the defendants, advising them that 

WEAC had tested their model 12 x-ray system and found that it did not comply with the 

required standards. Specifically, the unit did not comply with: (1) the x-ray tube current 

accuracy requirement, 21 CFR 1020.31(a)(4); (2) the light localizer illuminance and contrast 

ratio requirements, 21 CFR 1020.31(d)(2)(ii) and (iii); and (3) the labeling and certification 

requirements, 21 CFR 1010.2. The letter advised defendants that they could refute the findings 
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made by WEAC, request an exemption from the standards, or submit a corrective action plan 

that included notifying the purchasers of the violative equipment.

Following a meeting between CDRH and Alan R. Smith on September 24, 1993, CDRH sent a 

letter to the defendants, reiterating that defendants’ mobile and wall-mounted podiatry x-ray 

systems and portable, general purpose x-ray systems did not comply with the abovereferenced requirements. The letter also clarified an issue raised in the meeting concerning the 

meaning of the term "maximum SID [source to image receptor distance]."2 The letter stated 

that the "maximum SID," as used in 21 CFR 1020.31(d)(2)(ii) and (iii), is determined by 

equipment design and not by a label statement.

2. Defendants’ Request for a Variance from the Applicable Standards

Defendants, in a letter to CDRH dated November 4, 1993, requested that CDRH grant them a 

variance from the technique factor accuracy requirement, 21 CFR 1020.31(a)(4), the light 

illuminance and contrast ratio requirements, 21 CFR 1020.31(d)(2)(ii) and (iii), and the labeling 

and certification requirements, 21 CFR 1010.2, for the model 12 x-ray systems that they had in 

stock and in production at that time. Citing the financial burdens that would befall the company 

if it had to cancel pre-existing orders or retrofit or discard the systems, and the fact that no 

significant risk of injury existed if the systems were used at a SID of 21 inches, defendants 

asked CDRH to allow them to distribute the remaining model 12 units that they had in stock.

3. The Second Warning Letter

CDRH sent defendants a second Warning Letter on January 6, 1994. The letter stated that the 

defendants’ model 11 x-ray systems had the same light localizer and contrast ratio violations 

as the model 12. The letter demanded that defendants respond to CDRH within fifteen days to 

inform it whether the firm intended to refute the allegations, request an exemption from the 

standards, or provide purchaser notification and a corrective action plan.

4. CDRH’s Response to Defendants’ Request for a Variance

CDRH treated the defendants’ November 4, 1993 request for a variance for the model 12 units 

as a request for a variance for the model 11 units as well. In a separate letter dated January 6, 

1994, CDRH notified the defendants that their request for a variance was unacceptable for the 

portable, general purpose x-ray system.

By letter dated February 16, 1994, CDRH notified the defendants that their request for a 

variance and corrective action plan was approved for the mobile and wall-mounted podiatry x2 The performance standard for radiographic equipment is found in 21 CFR 1020.31. The visual definition 

standards that mobile and stationary general purpose x-ray systems must attain, including light illuminance and 

contrast ratio requirements, are found in 21 CFR 1020.31(d)(2)(ii) and (iii). These regulations both use the term 

"maximum SID" in defining the requirements.

Alan R. Smith contended that because his user manuals directed the user to place the x-ray system at a SID of 

21 inches, 21 inches was the "maximum SID." Therefore, he argued, his x-ray units met the light illuminance and 

contrast ratio requirements because they complied with the performance standards at a SID of 21 inches. The 

design of defendants' mobile and wall-mounted podiatry x-ray systems and portable, general purpose x-ray 

systems, however, allows the systems to attain a maximum SID of 40 inches. WEAC tested a model 12 unit at a 

SID of 40 inches and found that it did not comply with the performance standards. CDRH notified the defendants 

that because the x-ray systems could be used at a maximum SID of 40 inches, the systems would have to comply 

at that distance. CDRH explained that it was not sufficient simply to instruct users to operate the equipment at 21 

inches only.
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ray systems. The variance and corrective action plan applied only to those systems that had 

been manufactured and imported by the defendants prior to August 9, 1993.3 The letter 

explained that the corrective action plan required the defendants to do the following: (1) affix a 

label to the collimator of all podiatry units introduced into commerce prior to August 9, 1993, 

which stated, "This collimator is certified under the provisions of variance number 99V dated 

February 16, 1994, for podiatry use only at a maximum source to image distance of 21 inches;" 

(2) confirm the calibration of the tube current accuracy when they attached the variance label 

to each unit; (3) notify the users of the mobile and wall-mounted podiatry x-ray systems about 

the recall; and (4) provide CDRH with a time frame for implementing the corrective action plan 

and details on how the corrective action plan would be accomplished.

5. Subsequent Correspondence Between CDRH and Defendants

CDRH sent letters to the defendants dated March 11, March 31, and May 3, 1994. These 

letters advised defendants that they had not yet (1) submitted a corrective action plan for the 

portable, general purpose x-ray systems; (2) applied the variance labels to the mobile and 

wall-mounted podiatry x-ray systems already in commerce; (3) provided any plan for 

accomplishing the approved corrective action plan for the mobile and wall-mounted podiatry xray systems; and (4) provided a user notification letter and a list of end-user addresses to 

FDA’s District/Division/Program Office.

The defendants, in a letter to CDRH dated April 1, 1994, again questioned the definition of the 

term "maximum SID," contending that CDRH had incorrectly interpreted the language of the 

regulations. CDRH’s May 3, 1994 letter to the defendants reiterated the definition of "maximum 

SID."4 The letter further advised the defendants that their testing and quality control program 

for the portable, general purpose x-ray systems had not been approved, and therefore, they 

could no longer sell or introduce their general purpose models into commerce until an 

acceptable replacement collimator had been located or designed.

6. Correspondence Between the Defendants and the-------- Division/Program

On June 27, 1994, the defendants provided the District /Division/Program with draft versions of 

letters to be sent out to notify dealers who had purchased noncompliant x-ray systems from 

defendants. FDA’s District /Division/Program Director wrote the defendants on July 5, 1994, 

suggesting some changes in the wording of these letters. The District /Division/Program 

Director’s letter also notified defendants that they still had not met the conditions of the 

variance and they had not submitted any monthly recall status reports to the District/Division/ 

Program.

3 Defendants subsequently requested, by letter dated March 3, 1994, that x-ray units en route from Japan be 

included in the variance. CDRH denied this request by letter dated March 31, 1994. The letter explained that units 

that had not yet been introduced into United States commerce at the time the variance was granted, i.e., those 

that had not passed through United States Customs, were to meet full compliance without applying a variance.

4 On October 5, 1994, the defendants sent another letter to CDRH requesting clarification of the term "maximum 

SID" in the performance standard. CDRH responded by letter datedDecember 6, 1994, reiterating the definition of 

the term previously stated in the letter to defendants dated May 3, 1994. CDRH's letter also delineated all of the 

violations associated with the defendants' podiatry and general purpose systems. The letter advised defendants 

that they were required to report to the ________ Division/Program and that they were to submit information to 

CDRH regarding the corrective action plan for the general purpose systems.
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In a letter dated July 15, 1994, the defendants disputed that their recall was ineffective or failed 

to meet the conditions of the variance. The defendants stated that the letters notifying users 

that the systems did not comply with the standards could not be finalized yet. They estimated 

that they would notify the model 11 x-ray system users, by letter, during the first week of 

August 1994. The defendants explained that they could not establish a time frame yet for 

notifying the model 12 x-ray system users. The defendants also promised to submit monthly

reports to FDA’s District /Division/Program.

By letter dated September 12, 1994, FDA’s District /Division/Program addressed some of the 

issues raised by the defendants’ July 15, 1994 letter. The District /Division/Program informed 

defendants that: (1) they already should have sent out letters notifying users of the violative 

nature of the x-ray systems; and (2) they should have completed their corrective action plan for 

the mobile and wall-mounted podiatry x-ray systems. The defendants were further reminded 

that they had delayed initiating the corrective action plan for more than a year, and they were 

warned that further delays would not be tolerated.

7. The First Inspection

An inspection conducted on June 20, 1994 revealed that the defendants knowingly continued 

to distribute x-ray systems that did not comply with the applicable performance standards, 

even after receiving Warning Letters explaining that the machines violated the performance 

standards. Specifically, after February 16, 1994, the date on which the variance was approved 

for the podiatry x-ray systems that were in defendants’ inventory as of August 9, 1993, 

defendants sold one model 13 unit that had been imported prior to August 9, 1993 and was 

already in stock. The inspection further revealed that a shipment of ten model 11 units was 

received from Japan on October 10, 1993, and of that shipment, five were configured and sold 

as model 13 systems and one as a model 15 system. Therefore, the units received on October 

10, 1993 should had been excluded from the variance and corrected under the approved 

corrective action plan prior to distribution.

8. The Second Inspection

A reinspection of ABC held on July 18, 1995, revealed that since the previous inspection, the 

defendants had refurbished and resold eight podiatry x-ray units, two of which were sold 

without variance labels attached. The inspection also revealed that of twenty-four model 11 

units imported and received on November 4, 1994, the defendants sold one model 13 unit. The 

invoice noted that this unit, which was shipped to Macomb, Michigan, was to be installed in 

Canada. The inspection further revealed that defendants had not yet submitted a corrective 

action plan for the portable, general purpose x-ray systems.

Both inspections conducted at ABC identified a total of 270 violative model 11 and 12 x-ray 

systems that defendants had sold between January 21, 1988 and August 8, 1995. Defendants 

sold 121 of the 270 violative units between January 21, 1988 and January 18, 1991. Between

January 18, 1991 and August 8, 1995, defendants sold a total of 149 violative systems, 

including 22 systems that were sold after September 24, 1993, the date on which defendants 

were notified that the x-ray systems failed to meet the performance standards.

9. Defendants’ Failure to Comply with the Act

Each defendant has committed 441 violations of the Act. Defendants placed into commerce 

149 x-ray units that did not comply with the light illuminance, contrast ratio, and labeling and 
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certification requirements, 21 CFR 1020.31(d)(2)(ii) and (iii) and 21 CFR 1010.2, in violation of 

21 U.S.C. 360oo(a)(1). Defendants certified that 22 of these units met the applicable 

performance standards, despite their knowledge that the units did not comply with the 

standards, in violation of 21 U.S.C. 360oo(a)(5)(B). Finally, defendants failed to notify the 

users of the 270 noncompliant systems already in commerce, and they failed to bring the 270 

units into compliance, or replace the 270 units, or refund the cost of the 270 units, all in 

violation of 21 U.S.C. 360oo(a)(2).

To date, the defendants have failed to implement their corrective action plan for the mobile and 

wall-mounted podiatry x-ray systems, and they have failed to submit and implement a 

corrective action plan for the portable, general purpose x-ray systems. Furthermore, they have 

not provided notice to purchasers or provided any status reports of their activities to the District 

/Division/Program.

E. RESPONSIBILITY OF INDIVIDUAL DEFENDANT FOR THE ALLEGED VIOLATIONS

Mr. Smith, as president of ABC, has ultimate responsibility for all facets of the firm’s 

operations. The Warning Letters and other pertinent correspondence from FDA, as well as the 

investigators’ verbal discussions concerning the violations found, were all directed specifically 

to Mr. Smith. Mr. Smith personally responded to FDA’s letters, has personally met with CDRH 

to discuss the problems, and has had both the knowledge and authority to initiate the 

necessary corrections.

As the most responsible company official, Mr. Smith is legally liable in his individual capacity 

for civil penalties under the Act. 21 U.S.C. 360pp(b)(1); United States v. Park, 421 U.S. 658 

(1975); United States v. Dotterweich, 320 U.S. 277 (l934); United States v. Hodges X-Ray. 

Inc., 759 F.2d 557 (6th Cir. 1985).

F. ISSUES RAISED BY THE REFERRAL

By this referral, we are seeking an injunction and civil penalties rather than a seizure of 

products. The seizure remedy is inadequate in this case because the stock of units on hand is

small and the units cannot be identified as violative until configuration, consignment, and sale 

of the final components and accessories.5 Furthermore, an injunction would allow us to require 

the defendants to: (1) implement the approved corrective action plan for the mobile and wallmounted podiatry x-ray systems; (2) submit and implement a corrective action plan for the 

portable, general purpose x-ray systems; and (3) notify the Secretary and affected users of the 

violations.

Also, please note that WEAC only tested the portable, general purpose model 12. We know, 

however, that the portable, general purpose model 11, and the mobile and wall-mounted 

models 11 and 12 podiatry x-ray systems, all violate the same performance standards as the 

portable, general purpose model 12. The certifiable parts of all of these systems are exactly 

the same. The defendants were notified that none of these units complied with the 

performance standards in their meeting with CDRH on September 24, 1993, and they received 

a written Warning Letter to that effect on January 6, 1994.

5 A model 11 or model 12 unit in the stationary podiatry configuration meets all of the required performance 

standards, whereas the same unit in a mobile or wall-mounted podiatry configuration would violate the 

performance standards.
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Several other issues are raised by this referral. First we recommend two charges against 

defendants for their reintroduction of refurbished, used units into commerce. Mr. Smith claimed 

to have sold eight reconditioned units under the variance provisions, stating that the firm 

placed the proper variance label on the units. FDA inspectors checked six of the eight units 

and found that two of them did not contain variance labels. Accordingly, we have 

recommended charging defendants only with placing two of these reconditioned units into 

commerce with false certification. Second, although the defendants may claim that they have 

notified some dealer distributors to obtain end-user locations, defendants have not followed-up 

or attempted to notify end-users and correct the units at the user level, as CDRH instructed 

them to do as part of the variance granted by letter dated February 16, 1994. Finally, it is 

possible that ABC and Alan R. Smith will claim that they will be driven into bankruptcy if forced 

to pay $300,000 each in civil penalties. The financial solvency of the firm or the individual is

irrelevant to the imposition of liability, although it is an equitable factor that the district court 

may take into consideration when determining the proper amount of penalties. Hodges X-Ray, 

759 F.2d at 564.

G. CASE PROCESSING

We are enclosing a copy of our recommended Complaint for Injunction and Civil Penalties. 

The principal witnesses in the case will be the person who performed the test on the x-ray 

systems at WEAC, the FDA representatives who conducted the inspections and obtained 

pertinent records and affidavits, and experts from CDRH.

Please inform us promptly of the name of the attorney in your office to whom you assign this 

referral. [insert name and telephone number] is the assigned attorney in our office. We expect 

that she will participate fully in all phases of the case. All questions regarding this referral 

should be directed to her. If your office decides to forward this matter to the U.S. Attorney’s 

office, please notify us promptly of the date you do so and, if known, the name of the Assistant 

U.S. Attorney assigned to the case.

Very truly yours,

Chief Counsel

Food and Drug Administration

Enclosures

_______________________________________
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Exhibit 6-30

EXAMPLE OF COMPLAINT FOR INJUNCTION AND CIVIL PENALTY

IN THE UNITED STATES DISTRICT COURT

FOR THE NORTHERN DISTRICT OF ILLINOIS

EASTERN DIVISION

62.UNITED STATES OF AMERICA, 63.) 64.

65.Plaintiff, 66.) 67.Civil Action 

68.v. 69.) 70.No. 

71.ABC COMPANY, INC., a corporation, 72.) 73.Judge

74.And 75.) 76.

77.ALAN R. SMITH, an individual, 78.) 79.

80.Defendants 81.) 82.

COMPLAINT FOR PERMANENT INJUNCTION AND FOR CIVIL PENALTIES

The United States of America, plaintiff, by its undersigned attorneys, respectfully represents to 

this Honorable Court as follows:

INTRODUCTION

1. This action is brought pursuant to the Federal Food, Drug, and Cosmetic Act (the Act), 21 

U.S.C. 360pp to:

a. enjoin and restrain the defendants from violating 21 U.S.C. 360oo(a)(1), (a)(2), 

and (a)(5)(B), and

b. enforce the Act’s radiological health civil penalty provisions, 21 U.S.C. 

360pp(b)(1), in accordance with 28 U.S.C. 1355.

JURISDICTION AND VENUE

2. This Court has jurisdiction over this action pursuant to 21 U.S.C. 360pp(a) and 28 U.S.C. 

1331, 1337, 1345, and 1355.

3. Venue in this district is proper pursuant to 21 U.S.C. 360pp(c), 28 U.S.C. 1391(b), and 28 

U.S.C. 1395(a).

COUNT ONE

(Presenting a Cause of Action to Restrain Violations of 21 U.S.C. 360oo)

4. Defendant ABC Company, Inc. (ABC), is a corporation organized and existing under the 

laws of the State of Illinois and at all times relevant to the allegations in this Complaint, trading 
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and doing business at 38 Main Street, Peoria, Illinois, within the jurisdiction of this Court. The 

firm became incorporated on March 23, 1967.

5. Defendant, Alan R. Smith, an individual, is and has been since 1989, the President and

Chief Executive Officer of ABC. Prior to that time, Mr. Smith was the firm’s Vice President. He 

also currently holds the position of Corporate Treasurer. At all times relevant to this action, 

Mr. Smith performed his duties at 38 Main Street, Peoria, Illinois, within the jurisdiction of this 

Court. Mr. Smith has ultimate responsibility for all facets of the firm’s operations.

6. Defendants are, and at all times relevant to this action have been, engaged in the business 

of importing and manufacturing diagnostic x-ray systems which are "electronic products" 

within the meaning of 21 U.S.C. 360hh(2). Accordingly, each defendant was and is a 

"manufacturer" of electronic products within the meaning of 21 U.S.C. 360hh(3).

Failure to Cease Introduction of Violative Products Into Commerce

7. Pursuant to 21 U.S.C. 360ii(a), the Commissioner of Food and Drugs under authority 

delegated to him by the Secretary of Health and Human Services ("Secretary") under 21 CFR 

5.10(a)(3), promulgated regulations prescribing performance standards for diagnostic x-ray 

systems and their major components. These regulations are codified, in pertinent part, at 21 

CFR 1020.30-33.

8. On August 9, 1993, the United States Food and Drug Administration ("FDA") notified 

defendants that their model 12 x-ray systems failed to meet, inter alia, the light localizer 

illuminance requirements, the contrast ratio requirements, and the labeling and certification 

requirements, 21 CFR 1020.31(d)(2)(ii) and (iii) and 1010.2, respectively.

9. X-ray systems use a light localizer to define the light field so the operator of the equipment 

can adjust the x-ray field to the proper image receptor site. The contrast ratio requirement 

exists to permit the operator to align the film with the edges of the x-ray field. Failure of a 

system to meet these two requirements could cause the operator to visualize inaccurately the 

x-ray field, and could result in an x-ray field that is larger than necessary for the examination. 

An x-ray field that is too large or misaligned could overexpose the patient to radiation, and 

could unnecessarily expose sensitive body organs to radiation. If critical organs are exposed 

to radiation, there is an increased risk to the patient of cell damage and cancer.

10. Defendants met with FDA’s CDRH on September 24, 1993. At that time, CDRH notified 

defendants that their mobile and wall-mounted podiatry x-ray systems, models 13, 14, 15, and 

16, and their portable, general purpose x-ray systems, models 17 and 18, all failed to meet 

the requirements cited in the Warning Letter of August 9, 1993. By follow-up letter dated 

October 5, 1993, and by second Warning Letter dated January 6, 1994, CDRH reiterated to 

defendants that all of the above-mentioned units were noncompliant. On February 16, 1994, 

CDRH approved a corrective action plan for the podiatry units defendants placed into 

commerce prior to August 9, 1993. CDRH notified defendants that they were to submit a 

corrective action plan for the general purpose x-ray systems. From August 9, 1993 through 

March 30, 1995, the defendants exchanged numerous correspondences with CDRH and 

FDA’s Chicago District regarding the noncompliance of the x-ray units.

11. Nevertheless, after September 24, 1993, the date on which FDA notified defendants that 

their mobile and wall-mounted podiatry x-ray systems and their portable, general purpose xray systems did not comply with the applicable performance standards, the defendants sold 
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the following 22 units in violation of applicable performance standards, including 16 model 13 

units, 1 model 15 unit, 1 model 17 unit, and 4 model 18 units:

Model 13 Units (16 total)

Model 15 Unit (1 total)

151.SHIPPING DATE 152.INVOICE# 153.SERIAL# 154.SOLD TO

155.03/23/94 156.20635 157.16650 158.Podiatry (Stony Brook, NY)

Model 17 Unit (1 total)

159.SHIPPING DATE 160.INVOICE# 161.SERIAL# 162.SOLD TO

163.09/28/93 164.19359 165.16116 166.Supply Service (Gettysburg, PA)

Model 18 Units (4 total)

167.SHIPPING DATE 168.INVOICE# 169.SERIAL# 170.SOLD TO

171.10/15/93 172.19486 173.16360 174.Tech, Inc. (Walnut, CA)

175.01/06/94 176.20033 177.16357 178.Ocean, Ltd. (San Jose, CA)

179. 180. 181.16363 182."

183.03/09/94 184.20495 185.16361 186.A.S. (Calcutta, India)

By introducing into commerce these 22 x-ray systems that did not comply with the applicable 

performance standards, defendants committed 22 violations of 21 U.S.C. 360oo(a)(1).

12. Between March 20, 1991 and September 24, 1993, the date on which defendants were 

notified that their mobile and wall-mounted podiatry x-ray systems and their portable general 

purpose x-ray systems violated the applicable performance standards, defendants introduced 

into commerce the following 121 x-ray systems in violation of applicable performance 

standards, including 27 model 15 units, 1 model 16 unit, 49 model 13 units, 10 model 14 units, 

15 model 17 units, and 19 model 18 units:

83.SHIPPING DATE 84.INVOICE# 85.SERIAL# 86.SOLD TO

87.03/16/94 88.20603 89.16226 90.Podiatry Supply Co. (Heights, OH)

91.05/05/94 92.21004 93.16218 94."

95.12/01/94 96.22625 97.16996 98."

99. 100. 101.16997 102."

103.05/25/94 104.21175 105.16645 106."

107. 108. 109.16646 110."

111. 112. 113.16649 114."

115.06/06/94 116.21235 117.16235 118."

119. 120. 121.16648 122."

123. 124. 125.16651 126."

127.03/28/94 128.20668 129.16232 130.Healthcare (Brooklyn, NY)

131.10/04/94 132.22221 133.15549 134.Podiatry (Stony Brook, NY)

135.11/11/93 136.19660 137.13682 138.Supply Service (Gettysburg, PA)

139.04/20/94 140.20885 141.16231 142."

143.12/13/94 144.22708 145.16223 146."

147.02/07/95 148.23194 149.17002 150."
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Model 15 Units (27 total) 

187.SHIPPING DATE 188.INVOICE# 189.SERIAL# 190.SOLD TO

191.08/01/91 192.13639 193.14418 194.Medical Equipment Co. (Chicago, IL)

195.06/09/93 196.18608 197.16119 198.X-Ray Supply Corp. (Miami, FL)

199.12/18/91 200.14629 201.14424 202.Podiatry Supply Co. (Heights, OH)

203. 204. 205.14427 206."

207.01/29/92 208.14906 209.14576 210."

211.04/23/92 212.15588 213.15434 214."

215.03/11/93 216.17949 217.16040 218."

219.09/06/91 220.13904 221.14262 222.Healthcare (Brooklyn, NY)

223.10/02/91 224.14066 225.14423 226."

227.12/05/91 228.14507 229.14432 230."

231.01/24/92 232.14858 233.14582 234."

235.04/23/92 236.15577 237.15446 238."

239.05/22/92 240.15824 241.15439 242."

243.06/12/92 244.15966 245.15444 246."

247. 248.15967 249.15435 250."

251.04/02/91 252.12728 253.14258 254.Equipment Distributors (Syossett. 

NY)

255.12/05/91 256.14465 257.14428 258."

259.01/03/92 260.14691 261.14585 262."

263.01/22/92 264.14827 265.14580 266.Podiatry, Inc. (Freeport, NY)

267.02/14/92 268.15029 269.14567 270."

271.05/21/91 272.13100 273.14259 274.Supply Service (Tyler Hill, PA)

275.01/21/93 276.17558 277.16031 278."

279.02/11/93 280.17753 281.16034 282."

283. 284. 285.16045 286."

287.03/16/93 288.17993 289.16030 290."

291. 292. 293.16041 294."

295.04/21/93 296.18296 297.16123 298."

Model 16 Unit (1 total)

299.SHIPPING DATE 300.INVOICE# 301.SERIAL# 302.SOLD TO

303.01/28/93 304.17633 305.15339 306.Podiatry, Inc.(Freeport, NY)
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Model 13 Units (49 total)
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Model 14 Units (10 total)

307.SHIPPING DATE 308.INVOICE# 309.SERIAL# 310.SOLD TO

311.11/09/92 312.17043 313.15340 314.Equipment & Supply (Denver, 

CO)

315.02/12/93 316.17768 317.15471 318."

319.08/04/92 320.16348 321.15475 322.B & S Supply Co. (Pittsburgh, 

PA)

323.05/26/93 324.18584 325.16271 326."

327.01/21/93 328.17562 329.15219 330.Chris & Sons (Las Vegas, NV)

331.03/25/92 332.15347 333.15224 334.Pebbles & Sam Co. (Phoenix, 

AZ)

335.01/04/93 336.17435 337.15215 338."

339.11/20/92 340.17127 341.15338 342.Foot Service Inc. (Maspeth, NY)

343.01/21/93 344.17558 345.15335 346."

347.06/09/93 348.18619 349.16282 350.Southern Supply (San Jose, 

CA)

Model 17 Units (15 total)

351.SHIPPING DATE 352.INVOICE# 353.SERIAL# 354.SOLD TO

355.01/07/92 356.14739 357.14430 358.BB X-Ray (Detroit, MI)

359.01/14/92 360.14781 361.14575 362."

363.09/23/92 364.16689 365.15541 366."

367.07/08/91 368.13452 369.14270 370.Advantage Podiatry (Atlanta, 

GA)

371.06/03/91 372.13203 373.14429 374.Veterinary Supply (Baldwin, 

NY)

375.05/05/92 376.15670 377.15432 378.Tech, Inc. (Walnut, CA)

379.03/22/93 380.18029 381.16044 382.Podiatry Supply Co. (Heights, 

OH)

383.04/09/93 384.18210 385.16118 386."

387.05/17/93 388.18470 389.16047 390."

391.12/16/92 392.17335 393.16035 394.Brokerage (Orlando, FL)

395. 396. 397.16048 398."

399.11/13/91 400.14354 401.14420 402.S & S X-Ray Service 

(Pittsburgh, PA)

403.06/25/93 404.18729 405.16032 406."

407.10/04/91 408.14089 409.14251 410.X-Ray Supply (Provo, UT)

411.05/05/92 412.15682 413.15440 414.B.C.A. Inc. (San Francisco, 

CA)
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 Model 18 Units (19 total)

415.SHIPPING DATE 416.INVOICE# 417.SERIAL# 418.SOLD TO

419.04/22/93 420.18309 421.16270 422.36 X-Ray (Greenwood Lake, 

NY)

423.05/05/92 424.15670 425.15222 426.Tech, Inc. (Walnut, CA)

427.05/14/93 428.18592 429.16364 430.Tech, Inc. (Walnut, CA)

431. 432. 433.16365 434."

435.08/23/93 436.19135 437.16359 438."

439.05/11/93 440.18424 441.16273 442.Industries Inc. (Atlantic City, 

NJ)

443.04/07/93 444.18195 445.15216 446.X-Ray Service (Terra Haute, 

IN)

447.09/22/92 448.16680 449.15224 450.Available Supply (Boise, ID)

451.11/06/92 452.17034 453.15341 454."

455. 456. 457.15477 458."

459.02/02/93 460.17662 461.14878 462."

463. 464. 465.15342 466."

467.03/17/93 468.17999 469.15224 470."

471.04/13/93 472.18234 473.16268 474."

475.04/14/93 476.18238 477.16272 478."

479.06/07/93 480.18605 481.16275 482."

483.08/09/93 484.19019 485.16274 486."

487. 488. 489.16283 490."

491.05/07/93 492.18400 493.16276 494.California Labs (Los Angeles, 

CA)

By introducing into commerce these 121 x-ray systems that did not comply with the applicable 

performance standards, defendants committed 121 violations of 21 U.S.C. 360oo(a)(1).

Failure to Meet Certification Requirements

13. Pursuant to 21 U.S.C. 360kk(h), every "manufacturer" of an electronic product to which a 

performance standard is applicable is required to certify that such product conforms to all 

applicable performance standards. Such certification shall be based upon a test, in accordance 

with the performance standards, of the individual article to which it is attached. The 

manufacturer must furnish that certification to the dealer or distributor, in the form of a label or 

tag permanently affixed to or inscribed on such product. 21 CFR 1010.2.

14. Defendants failed to comply with the certification requirements for electronic products when 

they certified that the 22 podiatry units described in paragraph 11 met all applicable 

performance standards. The defendants, in the exercise of due care, had reason to know that 

such certifications were false or misleading in a material respect, in that FDA had notified them 

that the units failed to meet the applicable performance standards. Therefore, by affixing 

materially false or misleading certifications to the 22 units described in paragraph 11, the 

defendants committed 22 violations of 21 U.S.C. 360oo(a)(5)(B).

Failure to Notify and Failure to Repair, Replace, or Refund

15. Pursuant to 21 U.S.C. 360ll, every manufacturer of electronic products who discovers that 

an electronic product produced, assembled, or imported by him does not comply with the 

performance standards, must immediately notify the Secretary and the dealers, distributors, 

and/or first purchasers of any electronic products that have a defect or that do not comply with 

any applicable performance standard, and must also: (l) without charge, bring such product 

into conformity with the applicable standard or remedy such defect; (2) replace each product 

with a like or equivalent product which complies with each applicable standard; or (3) refund 
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the cost of such product. The Commissioner has promulgated regulations, 21 CFR 1002, 

1003, and 1004, which prescribe how such notification and correction shall be accomplished.

16. FDA determined that the 143 units described in paragraphs 11 and 12 did not comply with 

the light localizer, contrast ratio, and labeling and certification requirements, 21 CFR 

1020.31(d)(2)(ii) and (iii) and 1010.2, respectively.

17. Moreover, defendants sold 127 units in violation of applicable performance standards from 

January 21, 1988 to February l9, 1991. The sales of the 127 units included 71 model 15 units, 

50 model 13 units, and 6 model 17 units, and were as follows:
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Model 15 Units (71 total)
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Model 13 Units (5O total)
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Model 17 Units (6 total)

18. On February 16, 1994, FDA notified defendants that for all of the 270 violative units that 

were already in commerce, they were required to notify the first purchasers, dealers, or 

distributors of the x-ray units, and the end-users of such products, as required by 21 U.S.C. 

360ll(e), and they were further required to: (1) without charge, bring such products into 

conformance with the standard; (2) replace the products with like or equivalent products; or (3) 

make a refund of the cost of the products, as required by 21 U.S.C. 360ll(f).

19. Nevertheless, defendants failed to notify the first purchasers, dealers, or distributors and 

end-users of the 270 x-ray units described in paragraphs 11, 12, and 17, and they failed to (1) 

without charge, bring such products into conformance with the standard, (2) replace the 

products with like or equivalent products, or (3) refund the cost of the products, thereby 

committing 270 violations of 21 U.S.C. 360oo(a)(2).

COUNT TWO

(Presenting a Cause of Action to Enforce the Civil Penalties Provisions of 21 U.S.C. 

360pp(b)(1))

20. This Count realleges and incorporates by reference paragraphs 1 through 19 of this 

Complaint as if fully set forth herein.

21. Pursuant to 21 U.S.C. 360pp(b)(1), any person who violates 21 U.S.C. 360oo shall be 

subject to a civil penalty of not more than $1,000. Any violation with respect to any act or 

omission made unlawful by 21 U.S.C. 360oo constitutes a separate violation for purposes of 

21 U.S.C. 360pp(b)(1), and the maximum civil penalty imposed on any person for any related 

series of violations is not to exceed $300,000.

22. Each defendant committed a total of 435 violations of 21 U.S.C. 360oo, including: (1) 143 

violations of 21 U.S.C. 360oo(a)(1); (2) 22 violations of 21 U.S.C. 360oo(a)(5)(B); and (3) 270 

violations of 21 U.S.C. 360oo(a)(2). For each violation, a civil penalty of $1,000 may be 

imposed. Therefore, under 21 U.S.C. 360pp, a civil penalty of $300,000 per defendant may be 

imposed.

WHEREFORE PLAINTIFF PRAYS:
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I. That defendants, ABC and Alan R. Smith, and all of their officers, agents, representatives, 

employees, successors, assigns, heirs, attorneys, and any and all persons in active concert or 

participation with them, or any of them, be permanently restrained and enjoined under the 

provisions of 21 U.S.C. 360pp(a) from directly or indirectly doing or causing to be done any of 

the following acts:

a. Introducing, or delivering for introduction into commerce as defined in 21 U.S.C. 

360hh(4), any diagnostic x-ray system subject to, but not in compliance with, applicable 

performance standards in 21 CFR 1010 and 1020;

b. Issuing certification that x-ray equipment meets the applicable standards when they, in 

the exercise of due care, would have reason to know that such certification is false or 

misleading in a material respect;

c. Failing to comply with 21 U.S.C. 360oo(a)(2), which specifically requires manufacturers 

to (1) notify the purchasers of x-ray equipment that it does not comply with the 

performance standards; and (2) without charge, bring their manufactured diagnostic xray systems into conformity with the applicable standards prescribed in 21 CFR 1010 

and 1020, or replace such products with a like or equivalent product that complies with 

the applicable standards, or refund the cost of the violative products;

d. Failing to implement the FDA-approved corrective action plan for ABC’s mobile and wallmounted podiatry x-ray systems, models 13, 14, 15, and 16; and

e. Failing to submit and implement a corrective action plan for ABC’s portable, general 

purpose x-ray systems, models 17 and 18.

II. That the defendants, ABC and Alan R. Smith, each be required to pay to the plaintiff a civil 

penalty, pursuant to 21 U.S.C. 360pp(b)(1), in the amount of $300,000, for the violations herein 

above alleged in paragraphs 7 through 19. This amount represents a penalty to each 

defendant of $1,000 per violation of 21 U.S.C. 360oo, up to the maximum penalty of $300,000 

per defendant allowed pursuant to 21 U.S.C. 360pp(b)(1).

III. That the plaintiff be granted judgment for its costs herein, and that this court grant such 

other and further as it deems just and proper.

Dated this [insert date] day of [insert month and year].
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495. 496.Respectfully submitted,

497. 498.

499. 500.[insert name]

501.Assistant Attorney General

502. 503.

504. 505.[insert name]

506.United States Attorney

507. 508.

509. 510.[insert name]

511.Assistant U.S. Attorney

512.[insert address]

513.[insert telephone number]

515. 516.

517. 518.[insert name]

519.Trial Attorney

520.Office of Consumer Litigation

521.U.S. Department of Justice

522.P.O. Box 386

523.Washington, D.C. 20044

524.[insert telephone number]

OF COUNSEL:

[insert name]

Chief Counsel

[insert name]

Trial Attorney

Food and Drug Administration

5600 Fishers Lane

Rockville, Maryland 20857

[insert telephone number]