Regulatory Procedures Manual

Chapter 5 – ADMINISTRATIVE ACTIONS

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NOTE: The compliance officer (or, the center CSO/Scientist, if the action was centerinitiated) assigned to the administrative action should diligently pursue and actively 

monitor the progress of the case through the Agency review process to its conclusion. 

The Office of Strategic Planning and Operational Policy (OSPOP), Division of 

Enforcement (DE) can assist in situations where significant delays are experienced or 

assistance is needed to resolve technical, scientific, or policy issues. See also section 

on Ad Hoc Committees in Chapter 10.

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 Chapter 4 for more information.

This chapter contains the following sections.

Section Topic__________________________________________________

5-1 CITATIONS .....................................................................................................................................4

5-1-1 Purpose .................................................................................................................................4

5-1-2 Legal Authority......................................................................................................................4

5-1-3 Citation Under Multiple Laws ...............................................................................................4

5-1-4 Criteria For Citation...............................................................................................................4

5-1-5 Determining The Need For Citation......................................................................................5

5-1-6 Time Frames..........................................................................................................................6

5-1-7 Citation Procedures...............................................................................................................6

5-1-8 Determination Of Citees.......................................................................................................8

5-1-9 Setting Date For Meeting......................................................................................................8

5-1-10 Preparation Of Citation Documents......................................................................................9

5-1-11 Distribution Of Citation Documents....................................................................................11

5-1-12 Transfer of Meeting ............................................................................................................12

5-1-13 Correspondence With Attorneys........................................................................................13

5-1-14 Drug Advertising Citations ..................................................................................................13

5-2 SECTION 305 MEETING ...............................................................................................................14
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5-2-1 Purpose ...............................................................................................................................14

5-2-2 Authority .............................................................................................................................14

5-2-3 Preparation .........................................................................................................................14

5-2-4 Respondents' Request For Special Information..................................................................15

5-2-5 Conducting The 305 Meeting..............................................................................................15

5-2-6 Procedures After Meeting...................................................................................................23

5-3 ADMINISTRATIVE DETENTION OF FOODS...................................................................................24

5-3-1 Purpose ...............................................................................................................................24

5-3-2 Background .........................................................................................................................24

5-3-3 Issuing and Terminating Detention Orders.........................................................................26

5-3-4 Appeal of a Detention Order...............................................................................................36

5-3-5 Informal Hearing on Appeal of a Detention Order .............................................................43

5-3-6 Issuing the Decision on an Appeal ......................................................................................46

5-3-7 Administrative Record and FOIA Requests.........................................................................48

5-4 DETENTION OF FOODS – OTHER STATUTORY AUTHORITY.........................................................48

5-4-1 Purpose ...............................................................................................................................48

5-4-2 Authority .............................................................................................................................49

5-4-3 Criteria For Effecting And Terminating Detentions ............................................................50

5-5 ADMINISTRATIVE DETENTION OF DRUGS...................................................................................51

5-5-1 Purpose ...............................................................................................................................51

5-5-2 Background .........................................................................................................................51

5-5-3 Issuing and Terminating Detention Orders.........................................................................53

5-5-4 Appeal of a Detention Order...............................................................................................63

5-5-5 Informal Hearing on Appeal of a Detention Order .............................................................69

5-5-6 Issuing the Decision on an Appeal ......................................................................................72

5-5-7 Administrative Record and FOIA Requests.........................................................................73

5-6 ADMINISTRATIVE DETENTION OF DEVICES.................................................................................74

5-6-1 Purpose ...............................................................................................................................74

5-6-2 Detention of Devices...........................................................................................................74

5-6-3 Appeal Of A Detention Order..............................................................................................81

5-6-4 Informal Hearing On Appeal Of A Detention Order............................................................84

5-6-5 Requirements After A Hearing On Appeal Of A Detention Order ......................................87

5-7 LICENSE REVOCATION OR SUSPENSION .....................................................................................89

5-7-1 Purpose ...............................................................................................................................89

5-7-2 General................................................................................................................................89
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5-7-3 General Considerations for Revocation..............................................................................90

5-7-4 Issues Not Supporting License Revocation .........................................................................91

5-7-5 Revocation Procedures.......................................................................................................92

5-7-6 General Considerations For Suspension .............................................................................94

5-7-7 Suspension Procedures.......................................................................................................95

5-8 ORDERS OF RETENTION, RECALL, DESTRUCTION AND CESSATION OF MANUFACTURING 

RELATED TO HUMAN CELL, TISSUE AND CELLULAR AND TISSUE-BASED PRODUCTS (HCT/Ps)..............97

5-8-1 Purpose ...............................................................................................................................97

5-8-2 Background .........................................................................................................................97

5-8-3 General Considerations.......................................................................................................99

5-8-4 Procedures for Orders of Retention, Recall, or Destruction of HCT/Ps..............................99

5-8-5 Follow-Up to Orders of Retention, Recall, or Destruction................................................101

5-8-6 Procedures for Orders of Cessation of Manufacturing.....................................................102

5-8-7 Follow Up to Orders of Cessation of Manufacturing ........................................................104

5-8-8 Part 16 Hearing .................................................................................................................104

5-9 CIVIL MONEY PENALTIES AND NO-TOBACCO-SALE ORDERS ....................................................105

5-9-1 Civil Money Penalty Authorities........................................................................................105

5-9-2 Reduction Of Civil Money Penalties For Small Entities.....................................................112

5-9-3 Civil Money Penalty Recommendations...........................................................................112

5-10 DISQUALIFICATION OF CLINICAL INVESTIGATORS....................................................................113

5-10-1 Purpose .............................................................................................................................113

5-10-2 Criteria for Initiating Disqualification Proceedings...........................................................114

5-10-3 Initiating the Disqualification Process...............................................................................114

5-10-4 Notice of Initiation of Disqualification Proceedings and Opportunity to Explain (NIDPOE)

115

5-10-5 Consent Agreements.........................................................................................................116

5-10-6 Informal Conference with the Clinical Investigator..........................................................116

5-10-7 The Notice of Opportunity for Hearing (NOOH) ...............................................................117

5-11 EXHIBITS ....................................................................................................................................120
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5-1 CITATIONS

5-1-1 Purpose

This section describes the Food and Drug Administration's (FDA) procedures for issuing 

Section 305 Notices (21 USC 335). 

5-1-2 Legal Authority

FDA issues Citations under Section 305 of the Federal Food, Drug, and Cosmetic Act

(the Act or the FFDCA), which states:

"Before any violation of this Act is reported by the Secretary to any United States 

attorney for institution of a criminal proceeding, the person against whom such 

proceeding is contemplated shall be given appropriate notice and an opportunity 

to present his views, either orally or in writing, with regard to such contemplated 

proceeding."

21 CFR 7.84 provides requirements about the issuance of such notice and opportunity.

NOTE: Citation is to be used only when a prosecution recommendation is 

contemplated. Do not use a Citation for warning purposes. 

5-1-3 Citation Under Multiple Laws

On occasion, the same or related conduct that violates the Act may also constitute a 

violation of one or more other federal laws, such as the licensing provisions for biologics 

under the Public Health Service Act (42 U.S.C. Section 262), 18 U.S.C. Section 1001

(Fraud and False Statements), and 18 U.S.C. Section 371 (Conspiracy to commit 

offense or to defraud United States).

In such a case, identify the section of each law under which action is contemplated, and 

the specific actions considered to violate that law.

5-1-4 Criteria For Citation

The basic criteria for consideration of citation are as follows:

• A violation of the law has been established and the Agency has evidence in 

its possession to support the case in court.

• The violation is significant in terms of consumer protection.

Except in cases involving a health hazard, fraud, or extremely gross violations, prior 

warning must have been given to the firm and each individual involved. This prior 

warning may be in the form of conferences, previous meetings, letters, or discussions of 

FDA 483s at the conclusion of inspections or previous court actions. See RPM Chapter 
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10 for a discussion of Prior Notice. In instances where the prior warning was in the form 

of letters or a Section 305 Notice involving past violations, copies must have been 

directed to each individual to be cited. 

NOTE: Additional, more specific criteria in many areas may be found in Compliance 

Policy Guides (CPGs) and the Compliance Program Guidance Manual (CPGM). 

5-1-5 Determining The Need For Citation

The division compliance branch is responsible for deciding whether citation is 

warranted. The compliance officer assigned to the case should ensure that all samples 

and other evidence have been considered. The search for other samples and evidence 

may include:

1. Searching the Field Accomplishments and Compliance Tracking System 

(FACTS) for further information on the firm;

2. Checking with the laboratory to find out if there are other samples that are 

in-process and need to be analyzed;

3. Checking the collection report (C/R) on the initial sample to ensure that all 

related samples are attached; and,

4. Checking outstanding sample assignments in FACTS.

If there are other samples to be analyzed or the establishment inspection report has not 

been completed, and seizure has not yet been considered, you may wish to defer action 

until the entire case can be considered at one time. In such instances, discuss the 

matter with investigations branch and/or the laboratory to expedite processing of the 

report or the samples.

Conduct a thorough review of the evidence. For example, review the firm's regulatory 

history to determine who was responsible for the violations and whether prior warning 

has been given. Review inspection reports to ensure that any inspectional observations 

that are inconsistent with analytical results are addressed. Ensure that reserve samples 

are available, where required. In labeling violations, search the file to determine whether 

the firm has revised the labeling since the shipment of the samples in question.

A citation may be based solely on establishment inspection evidence. A minimum of two 

documentary samples covering violative products is desirable.

NOTE: Under normal circumstances, notice and an opportunity to present information 

and views will always be given before violations are reported for criminal prosecution. 

However, there are certain circumstances under which notice and opportunity need not 

be provided. Notice and opportunity need not be given when there is reason to believe 

that alerting the prospective defendants by a Section 305 Notice may result in the 

destruction of evidence or cause the proposed defendants to flee to avoid prosecution. 
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(21 CFR 7.84(a)(2)). In addition, notice and opportunity need not be given when further 

investigation by the Department of Justice is contemplated. (21 CFR 7.84(a)(3)).

Such situations are infrequent and should be approved on a case-by-case basis. Submit 

the facts to the center and request concurrence from the center, Office of Strategic 

Planning and Operational Policy (OSPOP), and the Office of Chief Counsel (OCC) 

when you do not believe providing notice and an opportunity for presentation of views is 

appropriate. 

5-1-6 Time Frames

All timeframes are in calendar days unless specified otherwise.

The following time frames apply to citations:

1. Division: fifteen (15) working days after analysis of most recent sample 

involved in case.

2. Center: fifteen (15) working days after receipt of the recommendation.

There may be good reasons for exceeding these timeframes in a particular case. For 

example, analytical procedures may be lengthy, or there may be a need to obtain 

assistance from other divisions to establish responsibility. Document the reasons for 

delays in the case file.

5-1-7 Citation Procedures

1. Prior Consultation with the Office of Criminal Investigations (OCI)

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 complexity 

or breadth, to OCI. This includes criminal search warrants, misdemeanor 

prosecutions, and citations.

Division management must communicate with its local OCI office before 

pursuing any criminal matter. 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 the Department of 

Justice that are responsible for handling FDA’s criminal cases. During this 

communication, OCI is to be provided with all the facts of the potential case 

and any additional information that is relevant to, or could impact, the case in 

any way. OCI will decide promptly whether or not it is interested in pursuing 

the case and will communicate that decision to the division. 
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If OCI chooses not to pursue a criminal matter, the division office, after 

considering the reasons for the declination, is at liberty to proceed with the 

case in accordance with the procedures in this chapter.

2. Authorization To Cite

Citation may issue either on a direct basis or after the submission of a 

recommendation to the appropriate center and receipt of concurrence to issue 

the Section 305 Notice.

It is incumbent upon the office issuing the Section 305 Notice to ensure that 

the firm and each individual to be cited have received prior warning, unless 

such warning is not required.

a. Direct Citation

CPGs give division offices authority to issue Section 305 Notices in cases 

where specific criteria are met. Most of these guidelines involve filth 

violations or noncompliance with standards. Check the CPG manual each 

time the division office believes citation is the action of choice to preclude 

submitting unnecessary recommendations to a center.

b. Citation Recommendation

Where the division office does not have direct citation authority, it should 

submit a citation recommendation to the appropriate center for approval.

The recommendation should include:

• the full background of the case, 

• the history of notification, 

• the facts supporting the violation(s) for which prosecution is being 

considered,

• the names and responsibilities of each individual to be cited, 

• the proposed charges, 

• the supporting samples,

• any labels, worksheets, and pertinent inspection reports, and

• any issues, concerns, discrepancies, or other problems with the 

case. 

The recommendation package should be well-organized, tabbed, and 

indexed. The recommendation should identify the location of supporting 

information it discusses. Interstate (IS) documentation remains the 

responsibility of the divisions and need not be submitted. However, the 

center may request IS documentation if there is a special need to review 

it.
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c. Citation Recommendation After or Concurrently with Seizure

When the division follows a seizure action with a citation recommendation 

based on the same underlying violations, it is acceptable to submit a 

memorandum that references information in the seizure recommendation, 

provided that the center has all of the labeling and other documents 

necessary to consider the citation.

When the division office is recommending citation at the same time it is 

recommending seizure, flag the recommendation memorandum as 

"Seizure and Citation Recommendation."

5-1-8 Determination Of Citees

1. Corporations, Partnerships, and Associations

Corporations, partnerships, and associations are "persons" under the Act, 

and may be prosecuted as separate legal entities. They should always be 

included in the citation.

2. Individuals

In every case, carefully consider citing individuals. Prior warning is a 

prerequisite except where the violation involves a danger to health, fraud, or 

where the violation is extremely gross.

It is FDA procedure to cite officers of corporations and members of 

partnerships and associations, when the available evidence establishes that 

the individual stood in a "responsible relationship" to the violation. As the U.S. 

Supreme Court stated in U.S. v. Park: "The Act imposes not only a positive 

duty to seek out and remedy violations when they occur but also, and 

primarily, a duty to implement measures that will insure that violations will not 

occur." 

Persons who have the power and authority, and therefore the responsibility, 

to carry out these duties and fail to do so are logical candidates for citation. 

Obtain the type of information needed to demonstrate responsibility from 

observations reported by the investigators, through correspondence and/or 

memoranda of conferences with the individuals, or through other means. In 

addition, if there is a need, obtain information from officers and individuals 

located at a parent plant, as well as persons at the inspected plant.

5-1-9 Setting Date For Meeting

If the firm and individuals to be cited are located within a reasonable proximity of the 

office in which the meeting is to be held, schedule the meeting for approximately ten 

(10) days after issuing the Section 305 Notice. If the citees must travel extensive 
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distances or wish to have a corporate attorney in attendance, or the violations involved 

are complex, schedule the meeting approximately twenty (20) days after issuing the 

Section 305 Notice.

When there are multiple citees, schedule a separate meeting for any citee who requests 

one in writing. The meeting may be held at a separate time on the same date or on a 

separate date. The citee must submit the request to the office that issued the Section 

305 Notice, and the request must be received at least three (3) working days before the 

date set in the notice.

5-1-10 Preparation Of Citation Documents

1. Section 305 Notice (Exhibit 5-1)

Insert the division address under the printed heading "Food and Drug 

Administration." Under the caption at the right, "In reply refer to," insert the 

key or file reference sample number for the action, and "et. al." if there are 

several samples involved. If there is only one product or class of products, 

such as "drugs," bakery products," etc., identify the product directly below the 

reference sample number. The complete list of samples will appear on the 

Charge Sheet along with the respective products. See Exhibits 5-2 and 5-3 

for examples of charge sheets.

Enter the date that Notice issues directly above the rectangle on "Section 305 

Notice" or centered under the city and state of the division's address.

In the space for addressee, insert the name and address of the firm or sole 

owner cited (primary citee). When the citation also names responsible 

individuals, address it in the following manner:

Standard Pharmaceutical Co. 

and Mr. Henry Jones

and Mr. John Doe

125 Main Street

Canton, Ohio 28531

(Do not show titles of individuals listed as citees.)

In the body of the Notice, following the phrase "with respect to the following," 

enter clear, concise statements identifying the specific interstate shipment 

and product for each sample on which citation is issuing. In each statement 

include 

• the name of the product, 

• sufficient quotation from the label to identify the brand, size, etc., 

• the date of shipment, 

• where the shipment originated, and 

• where and to whom it was consigned. 
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When there is more than one sample, show sample numbers in parenthesis 

following the description of each shipment. If there is insufficient space on the 

form to enter the samples and shipments involved, enter the notation "See 

Page 2" conspicuously in the body of the Notice and continue the additional 

information regarding the samples on a separate page captioned as follows: 

"Page 2 - Section 305 Notice".

NOTE: When charging violations involving items other than shipments, 

include a concise factual statement of the violations. See Exhibits.

Following the words, "A meeting has been scheduled for," insert the day, 

date, specific time and location of the meeting. Add any other information that 

may facilitate the citee's appearance in parentheses following this statement 

(e.g., availability of parking near the building).

Type the name of the Compliance Officer who will conduct the meeting at the 

bottom of the form and have that individual sign the copies mailed to the firm 

and each individual cited.

If individuals have been cited along with the firm, show distribution on all 

copies of the Notice under the parenthetical statement: "(IMPORTANT: NOTE 

ALL ENCLOSURES CAREFULLY)" such as: 1 cc to Mr. John Doe and to Mr. 

Robert Roe each with Charge Sheet and Information Sheet.

2. Charge Sheet (Form FDA 1854) ( Exhibit 5-2)

Use Form FDA 1854 (Model Charge Sheet Exhibit 5-2). Under the title, list 

each sample and product in ascending numerical order. If the list of samples 

is long, arrange it in two columns.

Under the heading "PROHIBITED ACT” state the section(s) of the law(s) 

violated and the statutory description from the law. In charges involving Title 

18 or Title 42, cite those laws.

At the left of the sheet, following the above paragraph type the word 

"CHARGES". If only one sample and charge are involved, enter the statement 

"The article is violative in that" followed by the non-legal description of the 

violation. In the case of multiple charges, enter the statement: "The article is 

violative in the following respects:" and list each charge separately, numbered 

as "1," "2," "3," etc.

When a number of samples and charges are involved, use the statement 

"The articles are violative in the following respects:" and list the charges as 

described above. Show the sample numbers involved at the left of each 

charge.
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State the charges in “lay language.” There is no need to reference specific 

sections of the Act (other than the "Prohibited Act") or the regulations. Exhibit 

5-3 contains examples of charges.

3. Legal Status Sheet (Form FDA 454) (Exhibit 5-4)

Use Form FDA 454. Exhibit 5-4 Legal Status Sheet. Enter the sample 

numbers involved in the citation in the upper right hand side of the form 

following the caption "Sample No."; and the date(s) of the alleged violations 

over the "(Date)" caption following line "A." If more than two dates are 

involved, show the earliest and latest dates only; for example, "3/3/94 thru 

4/12/94." The division office makes no other entries.

4. Information Sheet (Form FDA 466a) (Exhibit 5-5)

Use Form FDA 466 (Exhibit 5-5 Information Sheet) This form describes the 

purpose and nature of the meeting. It is not necessary to type any information 

on the form; however, it is mandatory that this form accompany the Section 

305 Notice sent to each individual cited.

5-1-11 Distribution Of Citation Documents

1. Distribute the Section 305 Notice, Charge Sheet, Legal Status Sheet, and 

Information Sheet as follows:

a. Send a signed, original copy of the Section 305 Notice, a Charge Sheet, 

an Information Sheet, and a Legal Status Sheet to the primary citee 

(generally the firm).

b. Send a signed copy of the Section 305 Notice, a copy of the Charge 

Sheet, and an Information Sheet, to each of the other citees, if it is a joint 

citation.

c. Forward one copy of the Section 305 Notice, together with one copy of the 

Charge Sheet, to the factory file, the reading file, and, if applicable, to the 

division resident post.

d. Retain three copies of the Section 305 Notice and the Charge Sheet in the 

Division Sample File for use when making a recommendation for 

disposition of the charges.

2. Mailing Instructions

Mail the Section 305 Notice in a regular, letter size envelope with the typed 

name and address of the citee. Do not use window envelopes. When 

individuals are cited along with a firm, circle or underline their names on their 

respective copies and mail each citee's copy in a separate envelope. Where 

the interests of the individual citees may be at odds, you may send the 

individual notices to the home addresses of the citees.
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Send the Section 305 Notice by certified mail with return receipt requested or 

by other method with proof of receipt.

3. Postponement of Meetings

Divisions may grant a reasonable postponement of a meeting upon written 

request by a citee or person representing a citee (see exception below). The 

length of the postponement will depend on particular circumstances but

should avoid excessive delay. Confirm the new date by a letter to the citee or 

representative who requested the postponement. Provide an information file 

copy to the center.

Exception: If an office in headquarters directed that the meeting be 

scheduled within a certain time frame, do not agree to postponements without 

first consulting with that office.

5-1-12 Transfer of Meeting

Occasionally citees will request a transfer of the scheduled meeting to another city in 

the division area, to another division office, or to Washington headquarters. The citee 

also has the option of answering by other means when personal appearance at the 

division headquarters is impractical.

1. Transfer Within Division Area

Do not grant requests for transfer of the meeting to another city in the division

area. The cost to the public of holding the meeting in another city outweighs 

any benefit or convenience to the citee.

2. Transfer to Another Division

A request to transfer a meeting to another division may be granted if 

reasonable grounds are presented, the request is addressed to the office that 

issued the Section 305 Notice, and the request is received in that office at 

least three (3) working days prior to the date set in the notice. See 21 CFR 

7.84(e). However, before granting the request to transfer the meeting, check 

with the division involved to make sure it agrees to the meeting.

Once the request is granted, verify the transfer by letter to the citee. Send 

copies of the letter to the new division with these attachments:

a. complete file on the samples involved

b. pertinent Establishment Inspection Reports (EIRs)

c. a FACTS printout of firm's record, if pertinent to the case

The home division should establish a temporary jacket as a record of the 

transfer. The transferee division will reschedule the meeting promptly and 

advise accordingly. This may be done by letter with reference to the original 
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Section 305 Notice and to the letter approving transfer from the original 

division. Forward copies to the home division.

After the meeting, send the Record and any exhibits to the home division

along with the original files.

Prepare a skeleton sample jacket or electronic file containing a copy of the 

Record, transcripts (if any), and copies of any collateral correspondence that 

may have issued on the case.

3. Transfer to Headquarters

Discourage requests by citees, before or during the meeting, to transfer the 

meeting to headquarters.

If, however, the citee insists that the meeting be held at headquarters, refer 

the request to the center involved. If granted, the center will inform the citee 

and home division of the new date set for the meeting. The division should 

then promptly forward the case file to the center for review and use during the 

meeting. The center will return the case file with the Record to the home 

division for disposition of the charges.

5-1-13 Correspondence With Attorneys

Attorneys representing clients who received a Section 305 Notice will often correspond 

with the division compliance officer regarding the Section 305 Notice. Because the 

issuance of a Section 305 Notice is confidential and generally not releasable to the 

public until all potential criminal matters are resolved, division compliance officers are 

responsible for ensuring that representatives of the citee provide appropriate 

documentation regarding their authorization. See 21 CFR 7.84(g).

It is not necessary to send citees copies of correspondence from their attorneys. 

However, when a citee is identified as having received a copy of the citee’s attorney’s 

correspondence, and we have responded to that correspondence, you may wish to 

send the citee a copy of our response.

5-1-14 Drug Advertising Citations

Due to the specialized nature of medical advertising, the Office of Prescription Drug 

Promotion (OPDP), Center for Drug Evaluation and Research (CDER) is the primary 

reviewer of drug advertisements. With few exceptions, OPDP will initiate citations based 

on violative drug advertisements.

After determining that an advertisement is violative and that citation is warranted, OPDP 

may initiate a request for samples to support an action. Samples that are obtained are 

routed to the home division of the responsible firm.
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OPDP will prepare citation instructions for issuance by the appropriate division. The 

instructions will specify whether the meeting is to be held at the division office or at 

headquarters. In most cases, meetings are held at headquarters.

The division will issue the Section 305 Notice in the normal manner, with a copy to 

OPDP. Following the meeting, OPDP will make a decision on the disposition of the 

charges and notify the division of that decision.

5-2 SECTION 305 MEETING

5-2-1 Purpose

This section summarizes the authority and procedures pertaining to the opportunity, 

under Section 305 of the Act, for a person to present their views before criminal 

prosecution is recommended to a United States Attorney.

5-2-2 Authority

The Secretary of Health and Human Services delegates broad authority to the 

Commissioner of Food and Drugs, and, unless specifically prohibited, gives the 

Commissioner the authority to redelegate this authority. Division Directors, Program

Directors, and Directors and Deputy Directors of the centers, are authorized under the 

redelegations to designate officials to hold hearings under section 305 of the Act.1 A 

Compliance Officer has authority to hold Section 305 meetings by such designation.

21 CFR 7.85 provides requirements about the conduct of such meetings.

5-2-3 Preparation

Except in unusual circumstances, the Compliance Officer who holds the meeting is the 

individual who issued the Section 305 Notice. As there is normally a time lapse between 

the issuance of the Section 305 Notice and the meeting date, the Compliance Officer 

should review the case immediately prior to the meeting. The Compliance Officer will 

need to be completely familiar with the charges, the law and regulations, and fully 

understand any analytical results and methodology that are part of the case (if 

necessary, through discussion with the analyst).

The Compliance Officer should assemble any necessary references, such as the Act, 

regulations, official compendia, etc. The Compliance Officer may also wish to mark or 

photocopy pertinent information in the files to avoid searches for data during the 

meeting. Such information may include records relating to samples, EIRs, and FDA 

1 Delegation of authority information is available on the Internet at 

www.fda.gov/aboutfda/reportsmanualsforms/staffmanualguides.
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483s, and documents relating to prior warnings to the firm or individuals in the form of 

citations, seizures, prosecutions, office interviews, letters, etc. To avoid the need to 

reread all of the material, it is best to organize this information at the time of the initial 

review, when preparing the Section 305 Notice.

5-2-4 Respondents' Request For Special Information

Respondents, their attorneys, and others occasionally attempt to obtain detailed 

information concerning the government's case. Such requests constitute requests for 

information under the Freedom of Information Act (FOIA). Point out that under the FOIA, 

they must submit requests in writing to the Director of FDA’s Division of FOI. Refer the 

requester to FDA’s Freedom of Information page and mention that the request must be 

processed according to law and FDA’s procedures. For example, FDA’s Associate 

Commissioner for External Affairs might determine that some or all of the information 

about FDA’s case may be withheld from disclosure under 21 CFR 20.62 (pre-decisional 

information, attorney work product, etc.) and/or 21 CFR. 20.64 (open investigatory, 

personal privacy, confidential source, etc.).

NOTE: If a respondent requests a portion of a sample, follow the procedures set forth in 

21 CFR 2.10(d) and 2.10(c).

5-2-5 Conducting The 305 Meeting

Respondents are occasionally quite upset due to the receipt of the Section 305 Notice 

and may tend to be discourteous or argumentative. The 305 meeting is not a debate 

and nothing can be gained by the Compliance Officer losing objectivity or by the 

respondent becoming abusive. The Compliance Officer should politely point out that the 

proceedings are not a trial but rather an opportunity for the respondents to give their 

side of the story and discuss any mitigating circumstances, corrective actions taken or 

planned, etc., and that FDA will consider this information when deciding whether or not 

to forward the case to the Department of Justice for the institution of criminal 

proceedings.

Do not make an unofficial audio or video recording of the meeting or permit any 

attendee to make an audio or video recording, without obtaining documentation from 

OCC that it is permissible. If an official transcript is desired, see 11(c) below.

The Compliance Officer should strive for continuity and relevancy. Some respondents 

may digress into time-consuming, irrelevant or repetitious discussion unless there is a 

diplomatic effort to focus upon relevant matters. Listed below is a suggested routine 

format for achieving orderly progress during the meeting:

1. Identification of Respondents

After the respondents have been introduced and seated, make notes showing 

the name, address, position, and business connection of each respondent. 
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The notes are for ready reference during the meeting and useful during the 

dictation of the record.

2. Failure of Respondent To Appear

Frequently, a cited individual does not attend the meeting. Determine if 

anyone present purports to represent such respondent and enter any 

responses into the record.

Designated representative(s) must have a signed written statement of 

authorization for each respondent for whom he/she has authority to act. If a 

representative appears without written authorization, the meeting may 

proceed with respect to any respondent for whom the representative appears, 

only if the Compliance Officer first verifies by telephone, or other appropriate 

means, the authenticity of the representative’s authority. See 21 CFR 7.84(g).

3. Attendance by Individuals Not Cited

Occasionally, an individual who was not named in the Section 305 Notice will 

appear and, during the course of the meeting, it will become apparent that the 

person shares the responsibility for the violation. In such instances, request a 

short delay and have the legal clerk prepare a supplemental Section 305 

Notice including the individual's name, present it to him/her, and proceed with 

the meeting.

Respondents may arrive at a meeting accompanied by adherents. When this 

situation occurs, the Compliance Officer should have each person identify 

themselves by name, state their relationship to the respondent, and, for the 

record, state that they are attending on behalf of the respondent. 

The Compliance Officer should then announce to the group that the meeting 

is not open to the public, that it concerns only the respondent, and that the 

only legitimate business other persons have in being there is that they are 

there at the request of, and on behalf of, the respondent; otherwise, they may 

not be present. 

Afterwards, the Compliance Officer will hear comments from all persons 

remaining present. 

If these actions are not taken, the respondent may claim that FDA deprived 

him/her of his/her rights to fully respond and explain.

4. More Than One Respondent

Requests for separate meetings should be in writing and should be received 

at least three (3) working days before the date set in the notice. 21 CFR 
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7.84(e). However, if there is more than one respondent, advise the 

respondents in advance that they are entitled to separate meetings if they so 

wish.

5. Legal Status Sheet, Form FDA 454 (Exhibit 5-4)

Ask for the Legal Status Sheet. The respondent may complete the sheet 

before or at the meeting. However, you may not demand completion or 

submittal of the sheet since there is no legal requirement that respondents 

furnish the sheet.

6. Explain The Purpose Of The Meeting And The Charges

Although the Information Sheet ( Exhibit 5-5), which accompanies the Section 

305 Notice and Charge Sheet, contains information concerning the reason for 

the notice, the Compliance Officer should reiterate the purpose of the notice 

prior to the discussion of the charges and advise the respondents that:

a. The meeting is being held in accordance with Section 305 of the Act to 

give them an opportunity to present any facts they believe are relevant 

prior to the FDA making its decision whether to recommend prosecution to 

the Department of Justice; and

b. The purpose of the meeting is not to resolve conclusively whether 

violations occurred, and therefore FDA will not present either witnesses or 

evidence at the meeting.

The Compliance Officer should briefly state the information in the FDA's 

possession, which indicates that violations of the Act (and other laws, if 

pertinent) occurred and that the individuals listed in the Section 305 Notice 

were responsible, either through their actions or their failure to take action. 

This may be by reference to the pertinent inspections, FDA 483s, warning 

letters etc., to provide a brief summary of the relevant time and acts. Request 

that the respondents follow their copies of the Section 305 Notice and Charge 

Sheet as the Compliance Officer either reads verbatim or summarizes the 

pertinent information concerning the shipment or receipt of each product and 

the charges pertaining to it, or the acts that constitute violations.

The Compliance Officer should ask the respondents whether they understand 

the charges. If the response is negative, answer any questions to ensure that 

the respondent understands the basis of the allegations. If the respondent 

indicates that the shipping or receiving dates are incorrect, clarify the 

discrepancies. If they indicate that they will make no admissions with regard 

to the shipment or receipt of the products, do not pursue the matter.
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7. Miranda Warning

In the past, there were questions regarding whether the Compliance Officer 

needs to give the "Miranda Warnings" prior to conducting a Section 305 

meeting. They are not to be given.

In Miranda v. Arizona, the court ruled that when an individual is taken into 

custody or otherwise deprived of his freedom and subjected to questioning, 

the person must be notified of his right to remain silent, that anything he says 

may be used against him, and that he has the right to an attorney. This 

warning does not apply to Section 305 meetings because a respondent to a 

Section 305 Notice is not "taken into custody or otherwise deprived of his 

freedom." In addition, even though not required, FDA notifies the respondents 

(Exhibit 5-5) that they are not compelled to answer and that an attorney may 

represent them. In 1976, in Beckwith v. United States, the Supreme Court 

held that even when the investigation has "focused" on an individual, he is not 

entitled to Miranda warnings unless he is in custody. In Oregon v. Mathiason, 

decided in January 1977, the Supreme Court held that a meeting at which the 

individual was free to leave did not require Miranda warnings.

8. Respondents' Statement

After discussing the purpose for the meeting and the charges, the 

Compliance Officer should invite the respondents to state their views with

respect to the alleged violations. Take notes regarding the various points 

covered by the respondents to ensure that pertinent comments are not 

inadvertently omitted when the summary is dictated.

Occasionally respondents appearing at a meeting present a prepared written 

response. In such instances the Compliance Officer should, if practical, read 

the written response aloud while the respondents follow their copies. The 

Compliance Officer should ask questions regarding any points that need 

clarification. In the dictation of the meeting summary, refer to the written 

response, which will be attached to the record as an exhibit, indicate that it 

was read aloud in the presence of the respondents, and include in the 

dictation only information concerning the points discussed for clarification.

Each respondent may present any information bearing upon the issues. This 

may consist of proposed or revised labeling, letters, laboratory data, 

sanitation contracts, etc. Identify each exhibit submitted by respondents at the 

meeting with the related sample number, date received, and the Compliance 

Officer’s initials. Place the identification at the top right hand corner of the 

exhibit, if it is possible to do so without obscuring any material.

Respondents may request that the Compliance Officer comment on the 

adequacy of the proposed corrections. Unless headquarters provided specific 
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instruction, refrain from commenting, and explain that comments may be 

provided after careful consideration of the submitted material and that it may 

involve headquarters review. Advise the respondents that the information will 

be included in the record as an exhibit.

9. Ensure Scope of Respondents' Responsibility

Usually respondents demonstrate their responsibilities while expressing their 

views with respect to the alleged violations. Normally, they express 

responsibilities in the form of comments such as "I hired extra men for 

sanitation" or "I ordered the destruction of the merchandise" etc.

If there are any doubts about the responsibility of any of the respondents, ask 

questions to ensure that you are not including individuals in a criminal 

proceeding who lack the authority to detect, prevent or correct violations. For 

example, ask who had the authority to change pest control firms or consulting 

laboratories, who hires or discharges employees for sanitation or quality 

control work, who directs labeling changes, and who expends monies for 

structural repairs and the purchase of new equipment, etc.

In addition to the responsibility of those who appear, the Compliance Officer 

may need to make inquiries regarding the responsibilities of an individual 

listed in the Section 305 Notice who does not appear. This could be 

particularly important in cases where officials of a company at a location other 

than the one inspected have been cited, but do not appear at the meeting.

10.Guaranties

Unless a respondent voluntarily includes as part of his presentation a 

guaranty related to the violations, explore thoroughly the question of whether 

one exists. Otherwise, the respondent may overlook the fact that he/she had 

a guaranty, until he/she or his/her attorney eventually presents it as a defense 

at trial.

If a respondent requests information regarding guaranties so that he/she may 

obtain them in the future, furnish a copy of 21 CFR 7.13.

If the respondent presents a guaranty at the meeting, do not comment upon 

its validity. Tell the respondents that the validity of the guarantee will be 

reviewed after the meeting.

11.Summary

At the conclusion of the meeting, the Compliance Officer will create an 

accurate summary of the meeting in the presence of the respondents, or at 
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their option, immediately after their departure. The respondents, for a variety 

of reasons, may wish to leave the meeting before the summary is completed, 

and should be afforded that option. In that event, a draft copy of the summary 

should be forwarded to the respondents, requesting their comments within ten 

(10) days, and explaining that without benefit of comment the record will 

stand as drafted. In the event respondents remain, they should be offered an 

opportunity to provide additional comments or corrections. Inform the 

respondents that if they disagree with, or wish to clarify, any of the statements 

they may do so after completion of the summary.

If respondents undertake to have long or irrelevant statements included in the 

summary, tactfully suggest that they may wish to submit a statement after the 

meeting, and that the statement will be included as an attachment to the 

Record. 21 CFR 7.85(g).

a. Required Statements

The Summary should always contain statements to the effect that:

i. The purpose of the meeting was discussed with the respondents and 

they understood that it was being held pursuant to Section 305 of the 

Act;

ii. The charges were discussed with the respondents and they 

understood them;

iii. The respondents indicated that the shipments had been made, or

received, as alleged. (If not admitted, or they have reservations, this 

information should be included);

iv. Information concerning the statements each respondent made 

concerning his scope of authority (responsibility) at the firm;

v. The respondents were asked if they had any corrections or 

comments to make (followed by their statements or a comment in the 

record that they had none);

vi. Copies of the Summary will be forwarded to the respondents; and,

vii. (In the final section of the record) that the Summary was dictated in 

the presence of the respondents and when asked if they felt that it

accurately and fairly summarized the discussion they indicated that it 

did (or did not in the following respect). If the respondents elected not 

to remain for the finalization of the summary, the final section of the 

draft should reflect that fact.

A copy of the typed summary should be provided to each respondent, and 

should be accompanied by a cover letter, which states that the firm and 

individuals have an opportunity to make any additions or corrections in 

writing within ten (10) days after receipt.
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b. Addendum to the Summary

Occasionally after the respondents have left the premises, the Compliance 

Officer will realize that significant information was omitted from the 

Summary. In such a case, an addendum to the Summary should be 

created and mailed to the respondents along with the Summary created in 

their presence. A cover letter should accompany the Summary and 

addendum pointing out the inadvertent omission. Request a letter from the 

respondents within ten (10) days indicating that the additional information 

had been discussed as recorded in the addendum.

A respondent may request that the meeting be reopened in order to 

submit new information for the record. Such a request must be timely, in 

writing, state the nature of the new information, the reason it was not 

previously available at the time of the original meeting and why the 

information cannot be submitted in documentary form. If the division

concludes that the meeting should be reopened to receive the new 

information, it may do so.

On occasion, respondents will request an additional meeting at 

headquarters to discuss the matter further. Such meetings are an 

extension of the Section 305 meeting and are governed by the procedures 

of this chapter.

c. Verbatim Transcript of Meeting

The respondent has the right to a verbatim transcript, at his expense. If 

exercising this right, the respondent must provide the necessary person or 

equipment to make the transcript. The respondent must submit a copy of 

such transcription to the division at no cost with an opportunity to make 

corrections and obtain agreement as to its accuracy. Under these 

circumstances, the Compliance Officer need dictate only a brief in-house 

summary after departure of the respondents, explaining the circumstances 

under which the verbatim transcript was made, who was present, etc. In 

this case, FDA does not prepare a "Summary".

The Compliance Officer may also order the meeting transcribed at FDA's 

expense. In this case, a copy of the transcription is provided to each 

respondent See 21 CFR 7.85(e).

d. Handling of Electronic Recording

If the meeting statement has been recorded, after transcribing, 

appropriately identify the recording medium with the date of the meeting, 

the name of firm cited, the sample numbers, and the transcriber's name. 

File the recording in the lead sample jacket and retain it until the ten 
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(10) -day period for review by the respondent has expired, then remove 

and destroy, or erase the recording.

e. Preparation of Summary

i. Method of Preparation

• Prepare the summary as a separate document, using the format 

in Exhibit 5-6 as an example.

• Include the following statement at the bottom of the copy provided 

to each respondent: "Copy of this Summary (or transcript) 

furnished to (respondent).”

• Include the transmittal letter advising respondents of the ten 

(10) -day period for additions or corrections.

ii. Number of Copies - Make sufficient copies for the following 

distribution:

• Original + 1 copy for center (hold for submission with case)

• One copy for division case file

• One copy for division establishment file on firm

• One copy for Resident Investigator, if desired

• One copy for division reading file

• One copy for each respondent

12.Multi-Session Meetings

The intent of the regulations is to limit multi-session meetings. Requests for 

changes in time and place of the meeting must be made in accordance with 

21 CFR 7.84(e). New evidence may be submitted in accordance with 21 CFR 

7.85(g). Nevertheless, a respondent may appear for a meeting, but claim 

he/she has further evidence to submit. If the request is reasonable, recess the 

meeting until a mutually agreeable date. Prepare only one Record covering 

both meetings.

When the respondent merely requests an opportunity to submit supplemental 

documentary evidence without further personal appearance, he/she may do 

as provided in 21 CFR 7.85(g). Mark additional information and/or 

documentation that is received within ten (10) calendar days after 

respondents received their copy of the summary or transcription of the 

meeting as an exhibit and add it to the Record.

13.Response By Mail

Frequently, respondents elect to respond in writing in lieu of making a 

personal appearance. It is not necessary to acknowledge receipt of a written 

response. However, it may be desirable to acknowledge a written response 
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when you also need to clarify some point of misunderstanding or oversight on 

the part of the respondent.

Hold correspondence to a minimum to avoid "holding a meeting by mail."

5-2-6 Procedures After Meeting

After the meeting (or written response, if any), a decision must be made as to 

disposition of the charges for each sample involved. The charges are disposed of by 

one or a combination of the following actions: Permanent Abeyance, Temporary 

Abeyance, or Prosecution.

1. Reporting Permanent Abeyance And Temporary Abeyance Cases

The division should process cases designated as in abeyance within seven 

(7) days after the meeting, with notification to the appropriate center, as 

described below.

a. Permanent Abeyance

Prepare a memorandum to the appropriate center(s) compliance office, 

headed "PA after CITATION" which provides the reason for placing the 

case in permanent abeyance (PA) and the planned division follow-up. 

Attachments should include a copy of the Section 305 Notice endorsed 

"PA (date and initials)", a copy of the Charge Sheet, a copy of the 

Summary, and any relevant information. Hold all copies the above 

documents in the division case file.

Forward a copy of the memorandum to the center(s), an endorsed "PA 

(date and initials)" copy of the Section 305 Notice, and a copy of the 

Charge Sheet to the division establishment file.

The Home Division’s Compliance Branch should update the Sample 

Disposition record(s) in FACTS with the appropriate information about the 

status of the samples.

a. Temporary Abeyance

Prepare assignments for necessary follow-up and forward copies to the 

appropriate center(s) compliance office. Hold the file in the Division

Compliance Branch. A case in TA is not considered closed.

2. Notification Of Non-Prosecution

When the Agency makes a final determination that prosecution will not be 

recommended for any of the persons named in a notice (i.e., the case is 

closed), the division that issued the 305 Notice will advise each person in 

writing of that fact. 21 CFR 7.85(h)(1).
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After the Agency decides to decline prosecution, that decision must be 

communicated to the office (generally a division office) that originated the 

citation recommendation to ensure that notification of non-prosecution issues 

in accordance with regulations. The FDA unit to which the recommendation 

was made, e.g., center, OSPOP/DE, OCC, is responsible for issuance of the 

declination to the originating office/division. Upon receipt of the declination, 

and absent a request for reconsideration of the recommendation, the 

originating office/division should issue the notification of non-prosecution 

within ten (10) working days.

When it is determined that one of several persons named in a notice will not 

be included in a recommendation for criminal prosecution, OCC will 

determine when that person will be notified (21 CFR 7.85(h)(2)). OCC will 

notify the division of this fact, and the district will issue the letter. The latter 

procedure applies when the Department of Justice declines to proceed with 

the entire case (21 CFR 7.85(h)(3)21 CFR 7.85(h)(3)) or declines to proceed 

against an individual (21 CFR 7.85(h)(4)). See Exhibit 5-7 for the model letter 

to use.

5-3 ADMINISTRATIVE DETENTION OF FOODS

5-3-1 Purpose

This section provides procedures for the administrative detention of articles of food.

5-3-2 Background

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002

provided FDA with the authority to administratively detain articles of food and made it a 

prohibited act to move a detained article or to remove or alter any mark or label 

required by a detention order. In 2011, the FDA Food Safety Modernization Act

amended the criteria for administrative detention to provide that an article of food may 

be detained when FDA has reason to believe that the article of food is adulterated or 

misbranded. 

Further, administrative detention protects the public by preventing movement of an 

article of food while FDA institutes appropriate action, which may include seizure under 

section 304(a) of the Act, injunction under section 302 of the Act, or other 

administrative actions, such as emergency permit control, mandatory recall, or food 

facility registration suspension. Administrative detention is implemented to gain 

immediate control over food when there is reason to believe the food is adulterated or 

misbranded. Administrative detention is designed for swift and immediate action to 

ensure that adulterated or misbranded products do not enter commerce or, if they are 

already in commerce, to stop them from reaching consumers. As such, administrative 
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detention is a tool that can be used to achieve immediate public health protection.

FDA’s administrative detention authority applies to articles of food in interstate and 

intrastate commerce, and food that is outside a United States Department of 

Agriculture regulated facility. See the Investigations Operations Manual (IOM), Section 

2.7 for further information on detention of food authorities under the FD&C Act and 

under the Federal Meat Inspection Act, the Poultry Products Inspection Act, or the Egg 

Products Inspection Act.

Administrative detention of food requires prior approval by the Division Director of the 

Division where the detained article of food is located or an official senior to the Division

Director (hereinafter referred to as the Division Director) (21 CFR 1.391). When 

ordering an administrative detention, the Division will need to act quickly to protect the 

public health. However, in situations where FDA has reason to believe the food is 

adulterated within the meaning of section 402(a)(4) of the FD&C Act (e.g., failure to 

have and implement a seafood or juice HACCP plan when required, or other critical 

violations of risk-based preventive control standards), the Division should immediately 

initiate a preliminary assessment (PA) call to consult with and obtain the concurrence 

of the appropriate Center compliance office, OCC, and OSPOP/DE prior to issuing an 

administrative detention order. In most situations of misbranding, the Division should 

immediately initiate a PA call, as well.

The period of the detention must be for a reasonable period, not to exceed twenty (20) 

calendar days. However, the period of detention may be extended up to a total of thirty 

(30) calendar days, if necessary to provide sufficient time to institute a seizure,

injunction or other administrative enforcement action.

Any person, who would be entitled to claim the detained article of food, if seized, may 

appeal the administrative detention and may also request a hearing on the appeal. The 

appeal and request for a hearing must be submitted to the Division Director that issued 

the detention order. If requested by the individual entitled to claim the detained article 

of food and granted by the presiding officer, the hearing must be held within two (2) 

calendar days after the appeal is filed. The presiding officer’s decision to affirm or 

revoke the detention must be made within five (5) calendar days after the appeal is 

filed.

Articles of food offered for import into the U.S. can be administratively detained. As 

with food generally, administrative detention will provide further assurance that the 

article of food will not be distributed in domestic commerce. 

Articles of food offered for import into the U.S. and subject to an administrative 

detention order under section 304(h) of the FD&C Act should be held in import status 

pending the outcome of the administrative detention process.

1. References 
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The regulatory authority for administrative detention of foods appears in 

section 304(h) of the FD&C Act and in 21 CFR 1.377-1.406, and 

associated regulatory authority and operations appear in 201(x) of the 

FD&C Act, 21 CFR Part 16, 21 CFR 10.19, and 21 CFR 10.45. IOM

Subchapter 2.7 Detention Activities also contains instructions for 

implementing the administrative detention authority.

5-3-3 Issuing and Terminating Detention Orders

Section 304(h) of the Act gives FDA the authority to administratively detain an article of 

food when it has reason to believe that the food is adulterated or misbranded. An 

administrative detention order temporarily prevents the potentially adulterated or 

misbranded food from being distributed in commerce while FDA determines the 

appropriate legal or other administrative enforcement action (e.g., Emergency Permit 

Control, food facility registration suspension, mandatory recall order) against the food 

or persons. Consistent with FDA’s mission to protect the public health, FDA will 

implement a risk-based approach in its use of administrative detention of food. The 

Division Director should consider the viability of legal action under sections 304(a) or 

302 of the FD&C Act or other administrative enforcement action while considering 

whether to order administrative detention.

Divisions should focus on, but are not limited to, food that poses either of the following 

food safety risks in establishing priorities for administrative detention:

• Reasonable probability that the use of, or exposure to, an adulterated or 

misbranded food will cause serious adverse health consequences or death (i.e., 

Class I recall and reportable food situations)

• Use of, or exposure to, an adulterated or misbranded food product that may 

cause temporary or medically reversible adverse health consequences or where 

the probability of serious adverse health consequences is remote (i.e., Class II 

recall situations).

The timing of the detention should be taken into consideration as much as possible 

without impacting public health to ensure it doesn’t impact on the available resources 

within the agency and other supporting agencies. Communicating the intent to order a 

detention to parties impacted by the order should be occurring as soon as possible for 

planning resources necessary to support the detention and subsequent seizure action.

1. Basis for Detention

An FDA employee, or state or local officer or employee commissioned by 

FDA as an officer of the Department, may order a detention, with appropriate 

FDA Division Director approval as described in this subsection (5-3-3, item 

#2, below), as part of his/her function of inspecting, examining, or 

investigating an article of food when FDA has reason to believe that the 
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article of food is adulterated or misbranded. See section 304(h) of the FD&C 

Act and 21 CFR 1.378.

2. Approval of Detention Order by the Division Director

The FDA Division Director in whose Division the article of food is located must 

approve the detention order. If prior written approval is not feasible, prior oral 

approval must be obtained and confirmed in writing as soon as possible. See 

21 CFR 1.391.

Prior to approving the detention order, the Division Director should verify that 

there is reason to believe that the article of food is adulterated or misbranded. 

When FDA has reason to believe an article of food is adulterated or 

misbranded the Division will need to act quickly to protect the public health. 

However, in situations where the food is adulterated within the meaning of 

section 402(a)(4) of the FD&C Act (e.g., failure to have and implement a 

seafood or juice HACCP plan when required, or other critical violations of riskbased preventive control standards), the Division should immediately initiate a 

PA call to consult with and obtain the concurrence of the appropriate Center 

compliance office, OCC, and OSPOP/DE prior to issuing an administrative

detention order. Appropriate supporting documentation should be provided 

before the PA call. A PA call initiates a collaborative process between the 

Divisions, Programs, OSPOP/DE, appropriate Centers (CFSAN or CVM) and 

OCC regarding possible Agency enforcement actions. PA calls are identified 

in Chapter 6 of the RPM for instructions on seizures and injunctions.

3. Notification

If the article of food presents a threat of serious adverse health consequences 

or death to humans or animals, the Division should also notify FDA’s 

Emergency Operations Center (EOC) at 1-866-300-4347. EOC will coordinate 

any emergency response activities associated with the food and will notify the 

appropriate office(s) (OFVM, CFSAN, CVM and ORA offices), either orally or in 

writing.

4. Issuing the Detention Order

The detention order must be issued in writing, in the form of a Detention Order

See Form FDA 2289. The ADO form must be issued in its entirety with no 

pages missing to ensure the firm has adequate notice. The detention order must 

be signed and dated by the FDA employee (usually an investigator) or 

commissioned officer who has reason to believe that the article of food is 

adulterated or misbranded. FDA must issue the detention order to the custodian 

(i.e., the owner, operator, or agent in charge of the place where the article of 

food is located). If this individual is not the owner of the article of food, FDA 

must provide a copy of the detention order to the owner of the article, if the 
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owner’s identity can be readily determined. See 21 CFR 1.392(a). Copies that 

cannot be hand delivered by an investigator must be sent as soon as possible 

via overnight delivery, with documentation of receipt of delivery.

If the article of food is detained in a vehicle or other carrier used to transport the 

detained article, FDA must provide a copy of the detention order to the shipper 

of record, importer of record (if applicable), the owner and operator of the 

vehicle or carrier, and the owner of the food, if their identities can be readily 

determined. Copies that cannot be hand delivered by an investigator must be 

sent as soon as possible via overnight delivery, with documentation of receipt of 

delivery.

5. Detention Order and Detention Tags – Forms

Section 2.7.2.3 of the IOM provides instructions for completing the Detention 

Order (Form FDA 2289). Section 2.7.2.4 provides instructions for completing the 

Detention Tag (Form FDA 2290), which should be affixed to the article of food 

subject to the detention order. If necessary, a label other than the Detention Tag 

may be used to identify the detained article of food, provided the label includes 

the information required in 21 CFR 1.382.

The detention order frames the issues for any appeal, including any informal 

hearing that may result from the detention. Therefore, the information on the 

order concerning the reason for detention is important. Provide clear direction to 

the plaintiff regarding the mechanism (courier, mail, email, fax) and to whom 

(DD) should they respond to the ADO.

The detention order must provide a brief, general statement of the reason(s) for 

the detention. There is no requirement that the order include all of the reasons 

for believing that the article of food is adulterated or misbranded. As such, the 

reasons outlined in the detention order do not limit the charges that may be 

included in a subsequent legal action. If the detention is based on classified 

information, this information must not be provided in the detention order.

6. Length of Detention

The article of food initially should be detained for twenty (20) calendar days, 

unless the Division believes that additional time will be required to institute a 

seizure or injunction. In such cases, the detention should be made for thirty (30)

calendar days at the time the order is issued.

If the article of food is detained for twenty (20) days and a seizure, injunction or 

other administrative action cannot be instituted against the article of food within 

that time frame, the detention can be extended to a total of thirty (30) days. If a 

detention is extended from twenty (20) to thirty (30) days, FDA will issue 
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another detention order and place new tags or labels on the product. The entire 

detention period may not exceed thirty (30) days.

7. Movement of a Detained Article of Food

An article of food offered for import into the U.S. and also subject to a detention 

order may not be delivered under the conditions of a bond held with U.S. 

Customs and Border Protection. Notwithstanding section 801(b) of the FD&C 

Act, any article of food subject to a detention order under section 304(h) of the 

FD&C Act may not be further delivered to any of its importers, owners, or 

consignees. However, this does not preclude the movement of the detained 

articles of food, at FDA's direction, to a secure facility under an appropriate 

Customs’ bond when that bond is required by Customs’ law and regulation as 

described below.

The detained article of food must be held in the location and under the 

conditions specified by FDA in the detention order. The movement of an article 

of food in violation of a detention order is a prohibited act under section 301(bb) 

of the FD&C Act.

Except as noted below, no person may transfer a detained article of food within 

or from the place where it has been ordered detained, or from the place to 

which it was removed, until the detention order is terminated by the Division

Director or the detention period expires, whichever occurs first.

The Division Director may approve, in writing, a request to modify a detention 

order to permit movement of a detained article of food for any of the following 

purposes under 21 CFR 1.381(c):

i. To destroy the article of food;

ii. To move the detained article of food to a secure facility under the terms of 

a detention order (see below);

iii. To maintain or preserve the integrity or quality of the article of food; or

iv. For any other purpose that the Division Director believes is appropriate in 

the case.

The required tags or labels must accompany the detained article of food during 

and after movement and must remain with the article of food until FDA 

terminates the detention order or the detention period expires, whichever occurs 

first, unless otherwise permitted by the Division Director who approves the 

modification of a detention order. 21 CFR 1.381(f).
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The Division Director’s letter approving a request to modify a detention order to 

allow the article of food to be moved should state (21 CFR 1.381(e)):

i. That the detained article of food remains under detention before, during, 

and after the transfer; and

ii. That FDA must supervise the transfer OR

iii. That FDA has declined to supervise the transfer and that the person who 

received the detention order, or his representative, must immediately 

notify the Division Director of the specific location to which the article of 

food was moved. Such notification must be sent to the Division Director 

who approved the order by fax, e-mail, or other written form as agreed to 

by the Division Director.

8. Movement to a Secure Facility at FDA’s Request

If, after a food is detained, FDA determines that removal to a secure facility is 

necessary, the article of food must be removed to a secure facility at the 

expense of the owner or claimant. Prior to moving the food to a secure facility, 

the owner or claimant must receive a modification of the detention order (21 

CFR 1.380(c)). The investigator who issued the initial detention order or other 

qualified official will issue a modified detention order, indicating:

i. The location to where the article of food must be moved; 

ii. That the detained article of food remains under administrative detention 

before, during, and after movement to a secure facility; and

i. The conditions of transportation applicable to the detained article of food.

As noted above in this subsection, item # 7, the detained article of food must not 

be moved to the secure facility until FDA modifies the detention order.

9. Legal Actions against Detained Food, Including Perishable Food

• Legal action - The Division should expedite the preparation of a legal action 

against the detained food or its owner, to obtain control over the temporarily 

(i.e., twenty (20) to thirty (30) calendar days) detained food, particularly 

perishable food. This will most often be through a seizure action.

NOTE: The timelines for perishable foods are significantly shorter than the 

general timelines provided in RPM Chapter 6 - Judicial Actions.

If FDA initiates a seizure action against a detained perishable food as defined 

in 21 CFR 1.377, we are required under 21 CFR 1.383 to send the seizure 

recommendation to the Department of Justice (DOJ) within four (4)

calendar days of issuing the detention order against perishable food, 
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unless there are extenuating circumstances. Extenuating circumstances 

include, but are not limited to, instances where the results of confirmatory 

testing or other evidentiary development requires more than four (4) calendar 

days to complete. If the fourth (4th) calendar day is not a working day, OCC

should advise DOJ on the last working day before the deadline of its plans to 

recommend a seizure and will send the seizure as soon as practicable on the 

first working day after the non-work day. 

All recommendations for legal action against a detained article of food must

be flagged to indicate the action involves product that is under administrative 

detention, must include the date the detention expires (and, for perishable 

food, the deadline for sending the recommendation to DOJ). For procedures 

on the approval process for seizures and injunctions, refer to the approval 

process in RPM Chapter 6 section 6-1-5. The Center, Division of Enforcement 

(DE), and OCC will concurrently review the case initiation memorandum 

(CIM) and supporting evidence. The Center compliance office, DE, and OCC 

should expedite their reviews to ensure that the legal action is to be instituted 

prior to expiration of the detention. A final, signed inspection report is 

preferred for seizure actions; however, a final narrative inspection report may 

not be necessary in all situations. For instance, seizure actions have been 

implemented on the basis of the FDA Form 483 accompanied by supporting 

evidence (e.g., photographs, official samples, copies of records, affidavits) 

documenting the violations. Divisions should be mindful that perishable food 

seizure actions must go to DOJ within four (4) calendar days after issuing 

the detention order. Decisions on suitability of the available evidence will be 

made on a case-by-case basis among the reviewing coordinators with final 

determination by OCC. Logistics should be discussed during the PA calls for 

both the administrative detention and the seizure action.

When the action is a seizure, the Division is responsible for coordination with 

the U.S. Attorney's office and the U.S. Marshals Service, to facilitate the 

prompt filing of the complaint and seizure of the food. The Division also is 

responsible for immediately providing oral or e-mail notice of the 

accomplishment of the seizure to the appropriate Center compliance office, 

DE, OCC, and the presiding officer of any in-process appeal of a detention 

order. CMS should be promptly updated with legal documentation including 

dates actions take place. 

When a seizure or injunction action is filed regarding the article of food 

involved in the detention order, the process for the appeal of a detention order 

terminates 21 CFR 1.402(c).

• Administrative Action – Divisions should initiate other administrative actions 

(i.e., emergency permit control, mandatory recall order, or food facility 

registration suspension), if appropriate and possible, during the period of 

detention. An administrative detention is in effect for at least twenty (20) 
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calendar days and will terminate if the detention period is not extended. If 

more time is necessary to enable FDA to institute an administrative action, 

the administrative detention can be extended, if necessary, for up to ten (10) 

calendar days, for a total of thirty (30) calendar days.

Administrative detention may be used in conjunction with other administrative 

actions, as necessary to control movement of the food while instituting that 

enforcement action. Please note that, administrative detention is distinct from, 

and not a prerequisite for, other administrative actions. Administrative 

detention does not alter the processes or timeframes established for other 

administrative actions. However, when multiple regulatory actions relating to 

the detained food or the implicated firm are initiated, the respective actions 

should be coordinated to the extent necessary and appropriate to control the 

movement and disposition of the detained food.

10. Termination or Expiration of Detention Orders

If FDA terminates a detention order, the Division Director will issue a detention 

termination notice releasing the article of food to any person who received the 

detention order or that person’s representative and will remove, or authorize in 

writing the removal of, the required tags or labels. See 21 CFR 1.384. While the

regulation does not give a time frame for FDA to issue the termination notice, 

we expect that we will normally issue the termination notice to the person who 

received the detention order within one (1) calendar day of the decision to 

terminate the detention order.

FDA will terminate a detention order when one of the following occurs:

i. FDA determines that the food is not adulterated or misbranded;

ii. FDA approves voluntary destruction and the destruction is 

accomplished;

iii. The detention order is appealed with or without an informal hearing and 

the presiding officer revokes the detention order; or 

iv. A seizure action under section 304(a) of the FD&C Act has been 

instituted in court and the goods have been seized by the U.S. Marshals 

pursuant to a court-issued warrant, or an injunction action under section 

302 of the FD&C Act has been instituted in court. 

The Division Director issues a Detention Termination Notice (Form FDA 2291) to 

the person(s) who received the Detention Order, or his representative(s) and, if 

movement of the article of food occurred pursuant to a modification of the 

detention order prior to the termination, to the person possessing the article of 

food. The notice may be issued in person or by mail. If the termination notice is 

issued by mail, request that the Detention Tags (Form FDA 2290) be returned. If 
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the termination notice is issued in person, see Section 2.7.2.5 of the IOM for 

instructions.

Once the detention period expires, the detention automatically terminates. In 

general, the Division Director will acknowledge the expiration and the release of 

the article of food, using the Form FDA 2291 Detention Termination Notice and 

the procedures described in this subsection.

11. Responsibilities For Issuing And Terminating Detention Orders

FDA responsibilities for issuing and terminating a detention order are as 

follows. Note, all components should identify alternate personnel to include in 

case activities should the assigned individual become unavailable or unable to 

remain on the case.

a. Division Responsibilities - The Division is responsible for:

i. Notifying the appropriate Center, OSPO/DE, and OCC as soon as it 

becomes aware of a situation where administrative detention may be 

appropriate. The Division is to make a determination that it has a 

reason to believe an article of food is adulterated or misbranded and 

then respond accordingly to protect the public health. In situations 

where the food is adulterated within the meaning of section 402(a)(4) 

of the FD&C Act (e.g., failure to have and implement a seafood or juice 

HACCP plan when required, or other critical violations of risk-based 

preventive control standards), the Division should immediately initiate a 

PA call to consult with and obtain the concurrence of the appropriate 

Center compliance office, OCC, and OSPOP/DE prior to issuing an 

administrative detention order. Appropriate supporting documentation 

should be provided before the PA call.

ii. Ensuring scientific and policy support from the appropriate Center, 

policy support of OSPOP/DE, and legal support of OCC before issuing 

a detention order based on 402(a)(4) adulteration.

iii. Acquiring the approval of the Division Director in accordance with 21 

CFR 1.391.

iv. Issuing the detention order.

v. Notifying the Director of DE, the senior compliance official or designee 

of the appropriate Center, and OCC by phone or e-mail that the order 

has been issued and supplying them with a copy of the detention order 

by the most expeditious means available (loading scanned copy into 

CMS, fax, express mail, e-mail, etc.) immediately after issuance. Notify 

the ACRA by Hot Item.

vi. Providing a copy of the supporting information, e.g., FDA Form 483, to 

DE compliance officer, the senior compliance official or designee of the 

appropriate Center, and OCC.
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vii. Notifying the Director of OSPOP/DE that the Division issued a 

detention order so that a presiding officer may be designated. At this 

time, the Division should provide a copy of the detention order and 

supporting information to the Director of OSPOP/DE so that he may 

provide a copy to the presiding officer, once one is designated.

viii. Once the food is detained, approving and monitoring the movement of 

detained food.

ix. Regularly monitoring the relevant phone, e-mail, and other incoming 

communications in the issuing Division’s office, even over weekends, 

for receipt of an appeal with or without a hearing from the firm whose 

food is subject to the detention.

x. If the Division receives any communications from the firm whose food 

is subject to the detention, the Division must immediately notify the 

relevant parties in OCC and the presiding officer. If a presiding officer 

has not yet been named, this information should be provided to the 

Director of OSPOP/DE who will give this information to the presiding 

officer once one is designated.

xi. Pursuing, with appropriate speed, the follow-up legal or administrative 

enforcement action.

xii. When warranted, issuing a Detention Termination Notice (Form FDA

2291) in a timely manner (usually within one (1) calendar day).

b. Center Responsibilities - The Center is responsible for:

i. Providing a prompt review and a determination on whether there is 

reason to believe the article of food is adulterated or misbranded in 

conjunction with the PA call. The response should be provided

concurrently to the Division, OSPOP/DE, and OCC by phone, fax, or email and to EOC and CORE, if involved.

ii. Providing written documentation from a senior compliance official of 

the appropriate Center (i.e., Director, Division of Enforcement, Office of 

Compliance, CFSAN; or Director, Division of Compliance, Office of 

Surveillance and Compliance, CVM) of the confirmation on whether 

there is reason to believe that the article of food is adulterated or 

misbranded, including documentation necessary to support the 

subsequent legal or administrative action.

iii. Working with the Division Compliance Office to identify evidence 

needed to support the legal case.

iv. Promptly notifying the Division, OSPOP/DE, and OCC of any issues or 

Center concerns that need to be resolved, prior to providing support for 

the legal and/or administrative action.
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v. Expeditiously reviewing the subsequent legal or administrative action 

recommendation and providing expert witnesses and other support, as 

appropriate, for the legal and/or administrative action.

vi. Coordinating the legal and/or administrative action with DE and OCC.

vii. Selecting a center expert to serve on the PO’s team should a hearing 

be granted. The enter expert should avoid participating in the 

investigation and action that is the subject of the hearing to remain free 

of bias or prejudice.

viii. If more than one program/center is involved. The centers will decide a 

lead center. Depending on which center takes the lead, the 

corresponding ORA program office will take the lead.

c. OSPOP/DE responsibilities – OSPOP, DE is responsible for:

i. Providing a prompt review in conjunction with the PA call. The 

response should be provided concurrently to the Division, appropriate 

Center and OCC by phone, fax, or e-mail and to EOC and CORE, if 

involved. 

ii. Coordinating the legal and/or administrative action with the Division, 

the appropriate Center and OCC.

iii. Arranging the designation of the presiding officer. This should be 

accomplished as soon as possible in the process once FDA makes a 

final determination to order a detention of food in consideration for the 

presiding officer’s responsibilities in the potential appeal and informal 

hearing process and to provide the presiding officer notice of his/her 

role as soon as possible. 

iv. Providing a copy of the detention order and supporting information to 

the designated presiding officer and confirming that copies of any 

communications between the firm whose food is detained, and the 

Division are provided to the presiding officer. 

v. Confirm that copies of all materials provided to the presiding officer are 

provided to the team of OCC attorneys assigned to provide legal 

support to the presiding officer. 

d. OCC responsibilities – OCC is responsible for:

i. Providing legal support and assessment during the PA call.

ii. Providing legal support to the personnel in the Division, appropriate 

Center, and OSPOP/DE involved in the administrative detention order 

and subsequent legal or administrative action.

iii. Assigning OCC attorney(s) to review information on the detention 

order.
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iv. Appointing a separate team of attorneys to provide legal support to the 

presiding officer for his/her role in making determinations on the 

informing hearing process and procedures.

5-3-4 Appeal of a Detention Order

1. Appeal, With or Without an Informal Hearing

Any person, who would be entitled to be a claimant for the article of food, if 

seized under section 304(a) of the Act, may appeal a detention order. The 

appeal must be submitted in writing, to the Division Director in whose Division

the detained article of food is located, at the mailing address, e-mail address, or 

fax number identified in the detention order. The appeal must include a verified 

statement identifying the appellant’s ownership or proprietary interest in the 

detained article of food, in accordance with Supplemental Admiralty Rule G of 

the Federal Rules of Civil Procedure. The appeal must include materials on 

which the appellant bases its request for an appeal. 

If the detention order is appealed, the Agency must provide the appellant with 

an opportunity to request an informal hearing. The request for a hearing must 

be in writing, must be included in the request for an appeal, and must conform 

to the time frames specified below. The presiding officer has the authority to 

deny a hearing when the appeal raises no genuine and substantial issue of fact 

and FDA is entitled to judgment as a matter of law. If the presiding officer, in 

consultation with OCC, determines that a hearing is not justified, the presiding 

officer will issue written notice of that determination and provide it to all parties 

explaining the reason for denial. See Exhibit 5-12 for Model letter denying 

hearing.

If the presiding officer grants the appellant’s request for a hearing, then an 

informal hearing will be held within two (2) calendar days after the date the 

appeal is filed. The informal hearing will be conducted in accordance with 21 

CFR Part 16 except where modified by 21 CFR 1.403.

2. Time Frames

The following time frames apply to filing an appeal of a detention order:

a. Perishable food - The appeal must be filed within two (2) calendar days of 

receipt of the detention order.

b. Non-perishable food - The appeal must be filed within ten (10) calendar 

days of receipt of the detention order. However, if the appeal includes a 

request for a hearing, the notice of intent to request a hearing must be filed 

within four (4) calendar days of receipt of the detention order, or the hearing 
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will not be granted. The notice of intent only relates to a hearing, which is 

part of an appeal. 

The date of filing the appeal will be the date the submission is received by the 

Division office.

If a hearing is requested, and FDA grants the request as outlined in this chapter, 

the hearing must be held within two (2) calendar days after the date the appeal 

is filed. The decision to affirm or revoke the detention must be made within five 

(5) calendar days after the appeal is filed.

For additional operational guidance regarding administrative detention of food 

offered for import into the U.S., Divisions should refer to the Administrative 

Detention of Imported Foods sub-chapter of Chapter 9 of the RPM.

A summary of these timeframes is presented in Exhibits 5-8 and 5-9 “Deadlines

for Administrative Detention of Food.”

3. Presiding Officer

The Director, OSPOP/DE, ORA will designate the presiding officer upon the 

Division Director issuing a detention order. The presiding officer for an appeal 

must be a Division Director or another FDA official senior to the Division Director

(21 CFR 1.404). Generally, a Director outside the Division where the detained 

article of food is located will serve as the presiding officer. The Director, 

OSPOP/DE, ORA should contact the potential presiding officer upon the 

Division Director issuing a detention order. If that individual is not able to serve 

as the presiding officer, the OSPOP/DE Director is responsible for arranging to 

have another Director or Agency official designated to serve as the presiding 

officer. All presiding officers must be designated consistent with current Agency 

regulations and delegations. OSPOP/DE will create a memorandum reflecting 

such designation and share it with the relevant parties.

Presiding Officer Responsibilities – The presiding officer is responsible for:

a. Making a determination on whether to grant or deny an appeal with or 

without an informal hearing request from the owner of the detained article.

Any person who would be entitled to be a claimant for the article of food, if 

seized under section 304(a) of the FD&C Act, may appeal a detention 

order and request an informal hearing as specified in 1.402. Procedures 

for establishing entitlement to be a claimant for purposes of section 304(a) 

of the FD&C Act are governed by Supplemental Rule C to the "Federal 

Rules of Civil Procedure."

b. If an appeal with a hearing is requested, making a determination on 

whether the owner has raised a genuine and substantial issue of fact 

justifying a hearing (21 CFR 16.26(a)), and if not, the presiding officer will 
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issue correspondence to deny the request for an informal hearing on the 

administrative detention order. If the hearing is denied, the presiding 

officer must still decide a timely appeal (i.e. whether the administrative 

detention was proper under FDA’s laws and regulations), as discussed 

below. All correspondence between the frim and the PO must be uploaded 

to CMS.

c. If there is an appeal, but no hearing is requested, making a determination, 

as discussed below, on whether the administrative detention was proper 

under FDA’s laws and regulations.

d. Making determinations on whether to waive, modify, or suspend any 

provision under 21 CFR part 16 as authorized by 21 CFR 10.19 and 21 

CFR 16.60(h).

e. Presiding over the informal hearing. A Division Director or an individual 

senior to the Division Director will be designated for this role. Although the 

designated official should be informed about an impending administrative 

detention, the individual should refrain from becoming involved in 

decisions relating to issuing or monitoring the detention order. After the 

detention order has been issued, the designee, if serving as presiding 

officer, must insulate himself/herself from all aspects of the detention 

except those relating to his/her responsibilities as a presiding officer for 

the hearing, if requested as part of an appeal.

f. Issuing appeal decisions in accordance with 21 CFR 1.405 as follows:

i. If there is an appeal with or without a request for a hearing, the 

presiding officer must issue a written report that includes a proposed 

decision confirming or revoking the detention by noon on the fifth (5th) 

calendar day after the appeal is filed; after providing four (4) hours in 

which the hearing participants could submit comments on the presiding 

officer’s report under 21 CFR 1.403(h), the presiding officer must issue 

a final decision. The final decision must be issued by the end of the 

fifth (5th) calendar day after the appeal was filed. If FDA either fails to 

provide the appellant with an opportunity to request an informal 

hearing or fails to confirm or terminate the detention order within the 

five (5)-calendar day period, the detention order is deemed terminated.

ii. Even if the presiding officer denies the hearing request, the presiding 

officer must issue a decision on the appeal confirming or revoking the 

detention within five (5) calendar days after the date the appeal is filed.

If the presiding officer fails to confirm or terminate the detention order 

during such five (5)-calendar day period, the detention order is deemed 

terminated. The PO’s hearing report must be uploaded to CMS.

iii. If the owner of the detained article appeals the detention order and

provides notice that he intends to request an informal hearing but does 

not file a timely request for an informal hearing, the presiding officer 

must issue a decision on the appeal confirming or revoking the 
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detention within five (5) calendar days after the date the appeal is filed. 

If the presiding officer fails to confirm or terminate the detention order 

during such five (5)-calendar day period, the detention order is deemed 

terminated.

In addition, 21 CFR 1.405 provides the following: 

a. If the presiding officer confirms a detention order, the article of food 

remains detained until we terminate the detention under 21 CFR 1.384 or 

the detention period expires under 21 CFR 1.379, whichever occurs first.

b. If the presiding officer terminates a detention order, or the detention period 

expires, FDA must terminate the detention order as specified under 21 

CFR 1.384.

c. Confirmation of a detention order by the presiding officer is considered a 

final Agency action for purposes of 5 U.S.C. 702.

d. See subsection 5-3-4 item #5(b) below for further responsibilities of the 

presiding officer.

4. Communications between Parties to the Hearing and the Presiding 

Officer

Parties to the hearing should avoid any off-the-record communication with the 

presiding officer. If any communication of this type occurs, it must be reduced to 

writing and made part of the administrative record of the hearing. The other 

party must be provided with a copy of the letter or memorandum of the 

communication and must be provided an opportunity to respond. See 21 CFR 

16.44(b). Presiding Officers should consider placing delivery and read receipts 

on the email communications between the PO and the plaintiff.

The person who writes a letter or memorandum of the meeting between a 

participant in the hearing and the presiding officer must send a copy to all of the 

participants. See 21 CFR 16.44(c).

5. Appeal Processing Responsibilities

Division Responsibilities

a. Preparation for an appeal should begin when the Division decides to 

detain an article of food. When the Division receives an appeal, the 

Division Director: 

i. Dates and time stamp the appeal and notifies the appellant of 

receipt of the appeal in writing.

ii. Notifies, orally or by email, the Center, DE, OCC, and the 

Presiding Officer of the appeal immediately and forwards a copy of 

the appeal to them as soon as possible by fax or electronically. 
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Requests assistance of the Center, OSPOP/DE and OCC as 

needed. OCC will designate attorneys to advise the 

Division/Center and attorneys to advise the Presiding Officer.

b. When the appeal includes a request for a hearing, the Division Director:

i. Prepares a general summary of the information that will be 

presented by FDA at the hearing in support of the detention order 

(“general summary”) and a comprehensive statement of the basis 

for the detention order (“comprehensive statement”), in accordance 

with 21 CFR 16.24(f). 

ii. EXCEPTION: When a detention order is based on classified 

information, 21 CFR 16.24(f) does not apply, and the Division should 

consult with OCC to determine whether the presiding officer can 

give the appellant notice of the general nature of the information 

consistently with safeguarding the information and its source (21 

CFR 1.403(e) and 1.406).

iii. The detention order (Form FDA 2289) may serve as the 

comprehensive statement only if the reason for detention is 

described in sufficient detail. See Exhibit 5-10 for an example of a 

model letter for reasonable notice of matters to be considered at 

hearing. The model letter includes a general summary and a 

comprehensive statement.

c. If the presiding officer grants the appellant’s request for a hearing, the 

Division Director forwards the general summary and the comprehensive 

statement to the appellant (excluding classified information), the presiding 

officer, and to the Center, OSPOP/DE and OCC representatives to the 

hearing. The Division office sends the documents immediately to all 

parties so that they arrive as soon as possible, but at least one (1) day 

prior to the hearing. However, if the detention order is based on classified 

information, the Division Director must not provide such information to the 

appellant. The Division Director must consult with OCC before issuing a 

detention order based on classified information.

d. At least one (1) day before the hearing, provides the appellant, presiding 

officer, Center, OSPOP/DE, and OCC representatives to the hearing, 

written notice of, or copies of, if they could not reasonably be expected to 

obtain copies, any published articles or written information to be presented 

at or relied on at the hearing. See 21 CFR 16.24(g).

e. When the appeal does not include a request for a hearing, the Division

Director: 

i. Forwards all the information that supports the detention to the 

presiding officer and the OCC attorneys representing the presiding 

officer. This includes FDA’s referenced general summary and 
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comprehensive statement and the information provided by the 

appellant on which the appellant bases its request for an appeal.

ii. The information should arrive no later than the third (3rd) calendar 

day after the appeal is filed, so that the information can be 

reviewed, and a decision rendered within five (5) calendar days 

after the date the appeal is filed.

Presiding Officer Responsibilities

a. When notified of an appeal, with or without a request for a hearing, the 

presiding officer:

i. Determines whether the appeal is not valid because the appeal has not 

been submitted within the established time frame or if the appeal does 

not demonstrate ownership or proprietary interest as required in 21 

CFR 1.402(b). The presiding officer will notify the appellant if he/she 

determines that the appeal is not valid.

ii. At the discretion of the presiding officer, if sufficient time is available, 

the presiding officer may notify the appellant of the requirement to 

provide written demonstration of ownership or proprietary interest and 

allow the appellant to re-submit the appeal with the required 

information. The submission of the appeal must be accomplished 

within the applicable timeframe. The OCC attorneys representing the 

presiding officer should be consulted on this issue. 

b. When notified of an appeal, and a hearing is requested, the presiding 

officer: 

i. Determines whether a hearing should be granted. A hearing will only 

be granted if the material submitted by the appellant raises a genuine 

and substantial issue of fact. See 21 CFR 16.26(a). A hearing will not 

be granted on matters of law or policy. 

ii. If the appeal does not clearly specify that a hearing is requested, a 

hearing will not be granted.

iii. If the presiding officer denies a hearing, the presiding officer notifies 

the appellant of the denial of a hearing in writing. See Exhibit 12 for an 

example of a model letter denying the appellant’s request for a 

hearing. 

iv. If the presiding officer grants a hearing, the presiding officer orally 

contacts the parties as soon as possible and sets a date for a hearing 

to be held within two (2) calendar days after the date the appeal is 

filed. The hearing normally takes place at the Division office where the 

goods are located. If practical, a hearing may be conducted via 

teleconference or video conference. 
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v. Provides all parties with written notification of the time, date, and 

location of the hearing, and secures technology (e.g., phone 

conference lines) for the hearing. 

vi. Provides the appellant with oral and written notification. See form letter 

as Exhibit 5-11: 

1. of those portions of 21 CFR part 16 that are excluded or 

modified under 21 CFR 1.403 and waived or modified for 

hearings on appeal of administrative detentions (see "Informal 

Hearing on Appeal of a Detention Order." See subsection 5-3-5

item # 2); 

2. that the informal hearing is not a public hearing per 21 CFR

16.60(a), in order to protect investigatory records compiled for 

law enforcement purposes that are not available for public 

disclosure under 21 CFR 20.64, or trade secrets and 

confidential commercial information that is not available for 

public disclosure under 21 CFR 20.61;

3. that the appellant should provide, at the hearing, a brief 

summary of any lengthy documents for presentation at the 

hearing (e.g., volumes of computer printouts);

4. that the appellant should provide the Division Director written 

notice of, or a copy of (if the Division Director could not 

reasonably be expected to obtain a copy), any published articles 

or written information for presentation at or relied on at the 

hearing, at least one (1) day before the hearing, if feasible, as 

required by 21 CFR 16.24(g); and

5. Of the requirements under 21 CFR 16.44(c). See Section 5-3-4, 

item # 4 "Communications between Parties to the Hearing and 

the Presiding Officer."

vii. When notified of an appeal, and no hearing is requested, the presiding 

officer orally notifies the:

1. parties that they should submit information supporting their 

positions as soon as possible, and no later than the third (3rd) 

calendar day after the appeal is filed, so that the information can 

be reviewed, and a decision issued within five (5) calendar days 

after the date the appeal is filed.

2. Appellant of the requirement under 21 CFR 16.44(c). See 

Section 5-3-4, item # 4 "Communications between Parties to the 

Hearing and the Presiding Officer," above.

OCC Responsibilities; OCC is responsible for:

a. Assigning OCC attorneys to represent the Division and Center during any 

appeal and hearing;
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b. Assigning different OCC attorneys to represent the Presiding Officer 

during any appeal and hearing;

c. Expediting review of information provided by the Division; and,

d. Working with the division to prepare for any hearing and appeal.

Center Responsibilities; The Center is responsible for providing:

a. scientific, technical, and policy support to the Division; and, 

b. representatives to the hearing, if necessary.

DE Responsibilities; DE is responsible for confirming that all:

a. Agency and OCC components are notified of and prepared for a hearing;

and,

b. documentation from the Division relating to the detention and hearing is 

provided to the Center compliance office and OCC.

6. Termination of an Appeal

The appeal process terminates if FDA institutes a seizure or injunction action 

regarding the article of food involved in the detention order. 21 CFR 1.402(c). A

seizure or injunction action is instituted when such action is filed in court.

If a seizure or injunction action is filed in court, the Division Director will notify the 

presiding officer. The presiding officer will issue a letter to the appellant that the 

appeal has been terminated because a seizure or injunction action has been filed in 

court. See Exhibit 5-24 for an example of a model letter notifying the appellant that 

the appeal has been terminated.

5-3-5 Informal Hearing on Appeal of a Detention Order

1. Background

Section 304(h)(4) of the FD&C Act requires FDA to provide the appellant 

with an opportunity for an appeal including an "informal hearing." Section 

201(x) of the FD&C Act defines this term. 21 CFR 1.403 requires that FDA 

conduct the hearing in accordance with 21 CFR part 16, Regulatory 

Hearing before the Food and Drug Administration, with the waivers and 

modifications noted below in 5-3-5 item #2. 21 CFR 16.5(b) advises that 

Part 16 procedures apply to the extent that they are supplementary to, and 

not in conflict with, the other procedures specified in a regulation that 

provides a person with an opportunity for a hearing. 21 CFR 10.19 and 21 

CFR 16.60(h) give the presiding officer the authority to suspend, modify, 

or waive provisions under part 16. A request for a hearing may be denied, 

in whole or in part, if the presiding officer determines that no genuine and 
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substantial issue of fact has been raised by the material submitted. The

regulations at 21 CFR 16.26(a)). 21 CFR 10.19 and 21 CFR 16.60(h) give 

the presiding officer the authority to suspend, modify, or waive provisions 

under Part 16.

2. Waivers and Modifications to 21 CFR Part 16

If FDA grants a request for an informal hearing on an appeal of a 

detention order, FDA must conduct the hearing in accordance with 21 

CFR Part 16, except that:

a. The detention order under 21 CFR 1.393, rather than the notice under 

21 CFR 16.22(a), provides notice of opportunity for the hearing and is 

part of the administrative record of the regulatory hearing under 21 

CFR 16.80(a);

b. A request for a hearing must be addressed to the FDA Division

Director in whose Division the article of food involved is located;

c. The provision in 21 CFR 16.22(b), providing that a person not be given 

less than three (3) working days after receipt of notice to request a 

hearing, does not apply;

d. The provision in 21 CFR 16.24(e), stating that a hearing may not be 

required to be held at a time less than two (2) working days after 

receipt of the request for a hearing, does not apply;

e. 21 CFR 1.406, rather than 21 CFR 16.24(f), describes the statement 

that will be provided to an appellant where a detention order is based 

on classified information;

f. 21 CFR 1.404, rather than 21 CFR 16.42(a), describes the FDA 

employees, e.g., Division Directors or other official’s senior to a 

Division Director, who preside at hearings;

g. The presiding officer may require that the hearing be completed within 

one (1) calendar day, as appropriate;

h. 21 CFR 16.60(e) and (f) do not apply to the hearing. The presiding 

officer must prepare a written report of the hearing. All written material 

presented at the hearing will be attached to the report. The presiding 

officer must include as part of the report of the hearing a finding on the 

credibility of witnesses (other than expert witnesses) whenever 

credibility is a material issue, and must include a proposed decision, 

with a statement of reasons. The hearing participant may review and 

comment on the presiding officer's report within 4 hours of issuance of 

the report. The presiding officer will then issue the final Agency

decision;
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i. 21 CFR 16.80(a)(4) does not apply to the hearing. The presiding 

officer's report of the hearing and any comments on the report by the 

hearing participant under 21 CFR 1.403(h) are part of the 

administrative record; 

j. No party shall have the right under 21 CFR 16.119 to petition the 

Commissioner of Food and Drugs for reconsideration or a stay of the 

presiding officer's final Agency decision; and,

k. If FDA grants a request for an informal hearing on an appeal of a 

detention order, the hearing must be conducted as a regulatory 

hearing pursuant to regulation in accordance with 21 CFR Part 16, 

except that 21 CFR 16.95(b) does not apply to the hearing. With 

respect to the regulatory hearing on an appeal of a detention order, 

the administrative record of the hearing specified in 21 CFR 

16.80(a)(1), (a)(2), (a)(3), and (a)(5), and 1.403(i) constitutes the 

exclusive record for the presiding officer's final decision on an 

administrative detention. For purposes of judicial review under 21 

CFR 10.45, the record of the administrative proceeding consists of the 

record of the hearing and the presiding officer's final decision.

In addition, 21 CFR 16.60(b), which provides that all parties may confront 

and conduct reasonable cross-examination of any person (except for the 

presiding officer and counsel for the parties) who makes any statement 

on the matter at the hearing, is modified. Reasonable questions will be 

allowed instead. Reference Congressional intent: House of 

Representatives Report no. 94-853. Also, see 21 CFR 16.5 and 16.60(h).

3. Conducting the Hearing

The presiding officer should inform the parties of the applicable 

modifications to 21 CFR Part 16 “Regulatory Hearing Before the Food 

and Drug Administration,” as provided for in the administrative detention 

regulation (21 CFR 1.403). The presiding officer will explain that the 

purpose of the hearing is to determine whether FDA, at the time of the 

detention and as charged in the detention order, had reason to believe

that the article of food is adulterated or misbranded. The FDA 

representative(s) must explain the basis for the detention and answer 

reasonable questions from the appellant.

The appellant may present relevant information to support his/her 

position that the article should not be subject to detention.

Both parties may conduct reasonable questioning of the other (section 

201(x) (4) of the FD&C Act; 21 CFR 16.60(b), as modified in Section 5-3-

5, item #2).
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The presiding officer will ensure that the material presented, and the 

questions asked are relevant to the issue of the hearing.

The presiding officer may, once the hearing commences, issue a 

summary decision on any issue in the hearing if the presiding officer 

determines from the material submitted in connection with the hearing, or 

from matters officially noticed, that there is no genuine and substantial 

issue of fact respecting that issue. 21 CFR 16.26(b).

The appellant may request that a transcript of the hearing be taken. 

However, the appellant must pay the cost of the transcript and furnish the 

presiding officer a copy for the record. FDA also may request a transcript 

of the hearing, in which case the costs are borne by the government.

The appellant may obtain a copy of the government transcript by 

submitting a request under the Freedom of Information Act (FOIA) (5 

U.S.C. 552 et seq.). 21 CFR Part 20 applies to the release of the 

transcript.

The presiding officer should notify the parties that his/her decision will not 

await transcription or correction of the transcripts so ordered.

4. Responsibilities For The Hearing: 

a. Center Responsibilities -

The Center will provide documents, witnesses, or office 

representatives for the hearing if requested by the Division or the 

OCC attorney counseling the Division. 

b. OCC Responsibilities -

OCC will provide counsel for the Division, the Center and/or the 

presiding officer, as appropriate, for the hearing.

c. Division and Presiding Officer Responsibilities -

Section 5-3-5, item #3 “Conducting the Hearing” includes 

responsibilities of the Division and the presiding officer.

5-3-6 Issuing the Decision on an Appeal

1. Decision on an Appeal after a Hearing

The presiding officer must issue a written report of the hearing that includes a 

proposed decision confirming or revoking the detention by noon on the fifth (5th)

calendar day after the appeal is filed. The hearing participants then have four 

(4) hours to review and comment on the report (21 CFR 1.405(a) and 1.403(h)).

If classified information was used to support the detention, then any 
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confirmation of the detention must state whether it is based in whole or in part 

on that classified information but will not reveal the classified information.

The presiding officer must issue a final decision within five (5) calendar days 

after the appeal is filed. If the presiding officer fails to confirm or terminate the 

detention order within this five (5) calendar day period, the detention order is 

deemed terminated. 21 CFR 1.405(a). The appellant should be orally notified of 

the termination immediately. A copy of the termination notice should then 

promptly be mailed to the appellant via overnight delivery with delivery 

confirmation. See Exhibit 13A for Model Letter Final Decision on Appeal 

Detention Order Confirmation and Exhibit 13B for Model Letter Final Decision on 

Appeal Detention Order Revocation.

2. Decision on an Appeal When Appellant Does Not Request a Hearing

If there is an appeal of the detention order, but the appellant does not request a 

hearing, the presiding officer must issue a decision on the appeal confirming or 

revoking the detention within five (5) calendar days after the date the appeal 

was filed. If classified information was used to support the detention, then any 

confirmation of the detention must state whether it is based in whole or in part 

on that classified information but will not reveal the classified information.

If the presiding officer fails to confirm or terminate the detention order during this 

five (5) calendar day period, the detention order is deemed terminated. 21 CFR 

1.405(b). The appellant should be orally notified of the termination immediately. 

A copy of the termination notice should then promptly be mailed to the appellant 

via overnight delivery with delivery confirmation. See Exhibit 13A for Model 

Letter Final Decision on Appeal Detention Order Confirmation and Exhibit 13B 

for Model Letter Final Decision on Appeal Detention Order Revocation.

3. Decision on an Appeal When Appellant’s Request for a Hearing is Denied 

If the presiding officer denies the appellant’s request for a hearing, the presiding 

officer must issue a decision on the appeal confirming or revoking the detention 

within five (5) calendar days after the date the appeal was filed. If classified 

information was used to support the detention, then any confirmation of the 

detention must state whether it is based in whole or in part on that classified 

information but will not reveal the classified information.

If the presiding officer fails to confirm or terminate the detention order during the 

five (5) calendar day period, the detention order is deemed terminated. 21 CFR 

1.405(c). The appellant should be orally notified of the termination immediately. 

A copy of the termination notice should then promptly be mailed to the appellant 

to via overnight delivery with delivery confirmation. See Exhibit 13A for Model 

Letter Final Decision on Appeal Detention Order Confirmation and Exhibit 13B 

for Model Letter Final Decision on Appeal Detention Order Revocation.
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5-3-7 Administrative Record and FOIA Requests

1. Administrative Record of Appeal with Hearing

The presiding officer should prepare the administrative record of the hearing, 

which consists of the following (21 CFR 1.403(k)):

i. The notice of opportunity for hearing and the response (e.g., the 

detention order that indicates the opportunity for a hearing and the 

appeal with a request for hearing or appeal without a request for a 

hearing);

ii. All written information and views submitted to the presiding officer in 

conjunction with the appeal with a hearing;

iii. Any transcript of the hearing;

iv. All letters and memoranda of meetings and communications between 

participants and the presiding officer referred to in 21 CFR 16.44(c); 

v. The presiding officer’s written report of the hearing which includes the 

decision confirming or revoking the detention, with a statement of the 

reasons. The report must include a finding on credibility of witnesses 

(other than expert witnesses) whenever credibility is a material issue; 

and

vi. The hearing participant’s comments on the report, including comments 

on the proposed decision. 21 CFR 1.403(h) and (i).

The Division should file the original Administrative Record of the Hearing with 

the firm’s official file at the Division office after completion of the report and 

send a copy to the appropriate Centers’ compliance office, DE, OCC and to 

the presiding officer. The Division compliance branch should also upload a 

copy into CMS.

2. FOIA Requests

21 CFR Part 20 applies to all requests for the administrative record and other 

documents relating to administrative detentions.

5-4 DETENTION OF FOODS – OTHER STATUTORY AUTHORITY

5-4-1 Purpose

This section contains the procedures for exercising FDA’s authority to detain meat, 

poultry and egg products as delegated to FDA under the provisions of the Federal Meat 

Inspection Act (FMIA), the Poultry Products Inspection Act (PPIA), or the Egg Products 

Inspection Act (EPIA).
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For the purpose of this section only, the following definitions apply:

1. Meat And Meat Products

The carcasses of cattle, sheep, swine, goats, horses, other equines, parts of 

such carcasses, and products made wholly or in part from such carcasses.

2. Poultry And Poultry Products –

The carcasses of domesticated birds, parts of such carcasses, and products 

made wholly or in part from such carcasses.

EXCEPTION - In the case of both meat and poultry products, certain products 

are exempted from the above referenced Acts by USDA because they contain a 

relatively small portion of meat or poultry or historically have not been 

considered meat or poultry products.

3. Eggs

The shell eggs of the domesticated chicken, turkey, duck, goose or guinea.

4. Egg Products

Dried, frozen or liquid eggs, with or without added ingredients, except products 

exempted by USDA because they contain a relatively small proportion of eggs 

or historically have not been considered egg products.

5-4-2 Authority

The Federal Meat Inspection Act, (MIA) as amended by Public Law (P.L.) 90-201; and 

Sections 19 and 20(b) of the Poultry Products Inspection Act (PPIA) as amended by 

P.L. 90-492; and Sections 19 and 23(d) of the EPIA provide certain detention powers.

The detention authority under the MIA and the PPIA provide that FDA representatives 

may detain articles subject to these acts if they are outside a USDA inspected plant and 

there is reason to believe that the products are adulterated or misbranded under the Act.

The detention authority under the EPIA provides that FDA representatives may detain 

products subject to that act if the products are found outside a USDA inspected plant 

and there is reason to believe that the products are in violation of the EPIA.

NOTE: Interstate Commerce is not a requirement for FDA jurisdiction over eggs and 

egg products because authority is based on violation of the Egg Products Inspection Act 

rather than the FFDCA.

The detention process is another regulatory tool to achieve compliance with the Act. It 

should be considered when such products are encountered during regular division

operations, on assignment, or as a follow-up to complaints. This procedure becomes 
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most appropriate when no immediate arrangements can be made for local or state 

authority to take control of the product, and/or it appears that the product will not be held 

voluntarily.

5-4-3 Criteria For Effecting And Terminating Detentions

Use the following procedures in detention situations:

1. Exercise Of Detention Authority

a. Meat and Poultry Products

Detentions may be made when all of the following criteria are met:

i. The article meets the jurisdictional requirement of interstate 

commerce in Section 304 of the Act and the article is in 

commercial channels;

ii. The article is located in an establishment that does not have 

USDA meat or poultry inspection service;

iii. The article is intended for human food or could readily be 

diverted into use for human food;

iv. The article is adulterated or significantly misbranded under 

the Act. 

NOTE: Detentions based solely on misbranding or on 

adulteration involving Section 402(b) of the Act must be 

cleared by the Center for Food Safety and Applied Nutrition 

(CFSAN) before detention; and,

v. The respective USDA, Food Safety Inspection Service 

Division Office has been notified and the action is coordinated 

with that office.

b. Eggs and Egg Products

Detentions may be made when all of the following criteria are met:

i. The article is in commercial channels. 

NOTE: Interstate commerce is not a requirement for 

jurisdiction under the EPIA;

ii. The article is located in an establishment that does not have 

USDA egg products inspection service;

iii. The article is intended for human food or could readily be 

diverted into use for human food; and,

iv. There is reason to believe the article is in violation of the 

EPIA.
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2. Termination Of A Detention Action

Detention should be continued until one of the following criteria is met:

a. State, county or municipal authorities have exercised jurisdiction 

and control of the article; or, in the case of meat or poultry, USDA 

has assumed control;

b. It has been determined that there is no significant violation of the 

FFDCA, or the EPIA, and the USDA has been notified that we 

intend to terminate the detention action;

c. The detained article has been denatured, destroyed or 

reconditioned under appropriate supervision;

d. The detention period of twenty (20) consecutive days, counting the 

day the detention was executed as the first day, has expired; or,

e. Seizure has been accomplished.

NOTE: Forward seizure recommendation as soon as possible after detention is 

accomplished, because the detention cannot be reinstated after the twenty (20)

day detention period expires.

3. Procedures

The IOM, Chapter 2, subchapter 2.7- Detention Activities contains specific 

inspectional instructions including initial reporting requirements, detention 

initiation, reconditioning, and termination.

5-5 ADMINISTRATIVE DETENTION OF DRUGS

5-5-1 Purpose

This section provides procedures and defines responsibilities for the Administrative 

Detention of drugs.

5-5-2 Background

The Food and Drug Administration Safety and Innovation Act (FDASIA) provided 

FDA with the authority to administratively detain drugs intended for human or 

animal use. It did so by amending section 304(g) of the Federal Food, Drug, and 

Cosmetic Act (FD&C Act) to add drugs to the list of products subject to 

administrative detention. As a result, FDA has authority to detain drugs, devices, 

and tobacco products under section 304(g) of the FD&C Act as amended by 

FDASIA. Section 301(r) of the FD&C Act was also later amended to make it a 

prohibited act to move a detained drug in violation of a detention order under 

section 304(g). This authority is distinct from the authority to administratively detain 
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foods under section 304(h) of the FD&C Act (see Sec. 5-3 of the RPM for 

procedures related to the administrative detention of foods).

The intent of administrative detention is to protect the public health by preventing 

the movement, distribution, and use of products believed to be adulterated or 

misbranded until FDA has time to consider what regulatory action it should pursue 

concerning such products, including initiating enforcement action, if appropriate. 

FDA may conduct a seizure under section 304(a) of the FD&C Act, an injunction 

under section 302 of the FD&C Act or take other actions. Administrative detention is 

designed to permit swift and immediate action to ensure that adulterated or 

misbranded drugs do not enter commerce or, if they are already in commerce, to 

stop them from reaching consumers. FDA’s administrative detention authority may 

only be exercised during an inspection of a facility or vehicle conducted under 

section 704 of the FD&C Act.

A detention order, before issuance, must be approved by the FDA Division Director 

in whose division the drugs are located. If prior written approval is not feasible, 

prior oral approval must be obtained and confirmed by written memorandum within 

FDA as soon as possible.

The detention period should be for 20 calendar days after the detention order is 

issued, unless the Division Director determines that a greater period is needed in 

order to seize the product, institute an injunction proceeding, or evaluate the need 

for legal action. In that case, he or she may extend the period by up to 10 calendar 

days.

Any person who would be entitled to claim the detained drug, may appeal the 

administrative detention and may also request an informal hearing on the appeal. 

The presiding officer’s decision to affirm or revoke the detention order must occur 

within five (5) working days after receipt of the appeal if there is no request for an 

informal hearing or if appellant requests that the informal hearing be held within 5 

working days from the appeal’s filing date. If the appellant requests that a 

regulatory hearing be held at a date later than 5 working days after the appeal is 

filed, but not later than 20 calendar days after receipt of a detention order, the 

presiding officer must hold the hearing at a date agreed upon by FDA and the 

appellant. The presiding officer must decide whether to affirm or revoke the 

detention within 5 working days after the conclusion of the hearing.

1. References 

The regulatory authority for administrative detention of drugs, relevant 

prohibited acts, and associated operations appears in sections 304(g), 

301(r), and 201(x) of the FD&C Act, and in 21 CFR 1.980, 21 CFR part 16, 

21 CFR 10.19, and 21 CFR 10.45. Investigations Operations Manual 

(IOM) Subchapter 2.7 Detention Activities also contains instructions for 
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implementing the administrative detention authority. See IOM 2.7.2.2 for 

high-level instructions for administrative detention of drugs.

5-5-3 Issuing and Terminating Detention Orders

Section 304(g) of the FD&C Act gives FDA the authority to administratively detain 

a drug when an investigator has reason to believe that the drug is adulterated or 

misbranded. An administrative detention order temporarily prevents the drug from 

being distributed in commerce while FDA determines whether to institute a seizure, 

injunction action, or other actions.

This enforcement tool should be considered when there is likelihood that the drug 

will be moved or distributed before a seizure can be accomplished. The Division 

Director should determine the applicability of their counterpart state’s authorities 

when reasonable. The Division Director should contact the appropriate state 

officials to inquire if the state is willing to conduct a state embargo. Even if the 

state has embargo authority and is willing to use such authority, the Division 

Director should still consult with the Center Compliance Official, OSPOP/DE and 

OCC to determine whether the state embargo or FDA administrative detention is 

the appropriate enforcement action. The Division Director should contemplate 

leveraging public health resources including requesting state assistance in making 

the decision on whether an ADO should be placed on an adulterated or 

misbranded drug product.

If the Division Director concludes that the person in possession of the drug will 

voluntarily hold the drug and will provide assurances that integrity and security will 

be maintained over the drug on hand and/or provides adequate assurance they are 

willing and able to correct all violations prior to shipment, there is no need to detain 

the drug. 

1. Basis for Detention 

An investigator or other authorized FDA representative who is performing 

an inspection may order a drug detention (with appropriate Division

Director approval) during an inspection of a facility or vehicle when he or 

she has reason to believe that the drug is adulterated or misbranded 

(section 304(g) of the FD&C Act and 21 CFR 1.980).

2. Approval of Detention Order by the Division Director

The Division Director in the geographic Division where the drug is located, 

must approve the detention order in writing. If prior written approval is not 

feasible, prior oral approval must be obtained and confirmed in writing as 

soon as possible (21 CFR 1.980(e)).

The Division Director should verify that there is reason to believe that the 
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drug is adulterated or misbranded. When there is reason to believe a drug 

is adulterated or misbranded, the Division Director may need to act quickly 

to protect the public health.

Prior to approving the detention order, the Division Director is expected to 

contact the Director of Compliance or their designee in the appropriate 

Center to ensure that the Center supports administrative detention. There 

should be sufficient reason to believe based on the observations made 

during the inspection that a product is adulterated or misbranded. 

Additionally, the Division Director should verify that the authorized FDA 

representative with reason to believe the drug is adulterated or misbranded 

has initiated a valid inspection under FDCA 704 (i.e. displayed credentials 

and issued a written notice of inspection to the most responsible person). 

(21 CFR 1.980(b)). Administrative detentions may not be ordered outside 

of an inspection (FDCA § 3014(g)(1)).

If the Division Director attempts, but is unable to make immediate contact 

with the senior compliance official and the Division Director has reason to 

believe a delay in issuance of an ADO covering finished product might 

result in serious injury or illness, the Division Director may immediately 

approve a detention order if one of the following exigent circumstances 

exist:

i. There is evidence of product tampering or intentional adulteration;

ii.A state or federal official has declared an emergency and the product 

appears to be adulterated or misbranded in response to that emergency 

after an FDA Notice of inspection has been issued and the FDA 

representative confirms the adulteration or misbranding appearance. 

iii. The firm is actively distributing finished product which is already 

subject to a center-approved Class I recall;

iv. There is visible, gross microbiological contamination in a sterile 

product;

v. The firm is distributing a finished sterile product with positive sterility 

test results or contains endotoxins that exceed specifications, and the firm 

does not claim the results are invalid;

vi. The firm is distributing a finished non-sterile product with positive test 

results for a known pathogen, and the firm does not claim the results are 

invalid;

If the Division Director approves a Detention Order under these circumstances, the 

Director must immediately notify the Center and attempt to gain center concurrence. 
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If the Division Director is unable to obtain center concurrence within 24 hours of 

establishing contact with the Center, the Division Director must immediately 

terminate the order unless the center requests more time to evaluate

Detention Order and Detention Tags – Forms

Section 2.7.2.3 of the IOM provides instructions for completing the 

Detention Order (Form FDA 2289). Section 2.7.2.4 provides instructions for 

completing the Detention Tag (Form FDA 2290), which should be affixed to 

the drug that is subject to the detention order. 

Because the detention order frames the issues for an appeal and informal 

hearing, if any, the violation must be identified as below. Although the 

agency may initiate judicial action based on any appropriate violation 

(whether or not listed as a basis for detention), FDA may not introduce 

additional basis for detention during an appeal or informal hearing if they 

were not included in the written order. The detention order must include 

the information required by 21 CFR 1.980(d)(3):

(1) a statement that the drugs identified in the order are detained for the 

period shown

(2) a brief, general statement of the reason(s) for the detention; 

(3) the location of the drugs; 

(4) a statement that these drugs are not to be used, moved, altered, or 

tampered with in any manner during that period, except as otherwise 

permitted in this document, without the written permission of the Division 

Director or designee; 

(5) identification of the detained drugs;

(6) the detention order number; 

(7) the date and hour of the detention order; 

(8) the period of the detention; 

(9) the text of section 304(g) and information about the appeal process 

located in 21 CFR 1.980(g)(1) and (2);

(10) a statement that any informal hearing on an appeal of a detention 

order must be conducted as a regulatory hearing under 21 CFR part 16, 

with certain exceptions as described in 21 CFR 1.980(g)(3).
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(11) the location and telephone number of the FDA Division Office and 

Division Director. A continuation sheet may be used when all the 

information will not fit on the form.

3. Length of Detention

Initially, the drug should be detained for no more than 20 calendar days, 

unless the Division Director determines that additional time will be required 

to institute a seizure or to evaluate the need for other action. In such cases, 

the Division Director should authorize a detention period not to exceed 30 

calendar days at the time the order is issued.

If the drug is detained for 20 calendar days and a seizure or other 

enforcement action cannot be instituted against the drug within that time 

frame, the detention can be extended to a total of 30 calendar days. If a 

detention is extended from 20 to 30 calendar days, amend the original 

detention order and place new tags or labels on the drug.

4. Movement of Detained Drug

No person may move a detained drug within or from the place where it has 

been detained until the Division Director terminates the detention order or 

the detention period expires, whichever comes first. This restriction 

prohibits any movement, use, alteration, or tampering with a detained drug 

(21 CFR 1.980(h)(1)), except to complete manufacturing or with written 

permission as explained below.

Movement to Complete Manufacturing (21 CFR 1.980(h)(2))

When a detained drug is not in final form for shipment (e.g. bulk tablets, 

unpackaged blister packs) and the manufacturer wants to complete work 

on the drug, then the manufacturer may move the drug within the 

establishment where it is detained in order to complete the work needed to 

put the drug in final form for shipment. In this instance, the manufacturer 

must orally notify the FDA official that issued the detention order or another 

responsible Division official of the movement as soon as it occurs. As soon 

as the drug is put into final form for shipment, it must be segregated from 

other drugs and the individual responsible for its movement must notify the 

FDA official that issued the detention order or another responsible Division 

official of its new location. Once in final form for shipment, the detained 

drug must not be moved further without prior written approval from the 

appropriate FDA official.

Other Movement with Written Permission (21 CFR 1.980(h)(3))
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The Division Director that issued the detention order or another responsible 

Division official may authorize, in writing, the movement of the detained 

drug for any of the following purposes:

i. To prevent interference with an establishment’s operations or harm to 

the drug.

ii. To destroy the drug.

iii. To bring the drug into compliance with the FD&C Act and its 

implementing regulations.

iv. For any other purposes that the FDA representative who issued the 

detention order, or other responsible FDA Division official, believes is 

appropriate in the case.

If the relevant FDA official grants permission to move the detained drug for 

any of the reasons listed above, the detained drug must remain segregated 

from other drugs and the person responsible for its movement must 

immediately notify the official orally or in writing who approved the 

movement, or another responsible FDA Division official, of the detained 

drug’s new location. 21 CFR 1.980(h)(4). Unless otherwise permitted by 

the FDA representative who is notified of, or who approves, the movement 

of the drugs, the required tags must accompany the drugs during and after 

movement and must remain with the drugs until FDA terminates the 

detention or the detention period expires, whichever comes first. 21 CFR 

1.980(h)(5). To effectuate this requirement, the authorizing official may 

specify in the written authorization how the tags should “accompany” the 

drugs in situations where it is unclear how the firm can comply with this 

requirement (e.g. firm needs to transfer drug from one large, tagged 

container into multiple containers for shipment/reprocessing.)

5. Termination or Expiration of a Detention Order

If FDA terminates a detention order, the FDA representative authorized to 

terminate the detention will issue a Detention Termination Notice releasing 

the drug to any person who received the detention order or that person’s 

representative and will remove, or authorize in writing the removal of, the 

required tags or labels (21 CFR 1.980(j)). The Division Director has the 

authority to terminate a detention. Generally, the Program Division Director 

or program division employees will serve as the “FDA representative 

authorized to terminate” the detention and the Division Director, or other 

FDA representative authorized to terminate the detention, shall endeavor to 

issue the termination notice as soon as possible after one of the following 

occurs: 
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i. FDA determines that the drug is not adulterated or misbranded.

ii. FDA approves the voluntary destruction of the drug and the 

destruction is accomplished.

iii. FDA approves voluntary compliance by reconditioning or other means 

(e.g., relabeling, voluntary recall, etc.).

iv. A seizure action under section 304(a) of the FD&C Act has been 

instituted in court and the goods have been seized by the U.S. Marshals 

pursuant to a court-issued warrant. The filing of a complaint does not 

automatically terminate a detention order.

v. The detention period expires.

vi. The detention order is appealed, with or without an informal hearing, 

and the presiding officer revokes the detention order.

If any of the above conditions occurs, the Division Director must approve 

the termination of detention order and may do so by giving oral or written 

approval. The Division Director, or the investigator or compliance officer at 

the direction of the Division Director, issues a Detention Termination 

Notice (Form FDA 2291) to the person(s) who received the detention 

order. This termination notice should be provided to the person identified 

in the order or modified order who currently possesses the detained drug. 

Per 21 CFR 1.980(k), the termination notice must include or be 

accompanied by a statement advising the owner, operator, or agent in 

charge to keep records concerning the detention for the remainder of the 

two-year period from the date of detention, or such shorter period as FDA 

directs.

The Detention Termination Notice may be issued in person or by mail. If 

the Division issues the termination notice by mail, then the Division must 

also request that the Detention Tags (Form FDA 2290) be returned. The 

Division should, as matter of practice when a Detention Termination 

Notice is sent by mail, concurrently verbally notify the person who 

received the original detention order, or that person’s representative, that 

the detention has been terminated. Any delivery receipt should be 

documented.

If the termination notice is issued in person, see Section 2.7.2.5 of the 

IOM for instructions. If the Division Director gives oral approval, then the 

Division Director should issue a written confirmation as well.

6. Responsibilities for Issuing and Terminating Detention Orders
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The responsibilities of the relevant FDA components involved in issuing 

and terminating a detention order are set forth below.

a.Program Division Responsibilities - The Division is responsible for: 

i. Verifying that the investigator has reason to believe a drug is 

adulterated or misbranded and then responding accordingly to 

protect the public health.

ii. Notifying the appropriate Center, OSPOP/DE, OCC, and other 

applicable program divisions as soon as it becomes aware of a 

situation where administrative detention may be appropriate. 

iii. Determining whether the person in possession of the drug will 

voluntarily hold the drug and provide assurance that integrity and 

security will be maintained over the drug on hand, in which case, 

there is no need to detain the goods.

iv. Exploring the applicability of state regulatory oversight to 

include embargo authorities and license suspensions instead of 

administrative detention to conserve FDA resources (See 5-3-3 

Issuing and Terminating Detention Orders).

v. Ensuring support from the senior compliance official of the 

appropriate Center and OCC before issuing a detention order,

unless exigent circumstances exist, and the Division attempts to 

make contact, but Center or OCC are not immediately available. 

vi. Obtaining the approval of the Division Director in accordance 

with 21 CFR 1.980(e).

vii. Obtaining OCC approval of draft detention order (unless 

exigent circumstances exist, and the Division attempts to make 

contact, but OCC is not immediately available)

viii. Issuing the detention order on Form FDA 2289, providing a 

brief, general statement of the reason(s) for the detention and 

stating the charge in the order in plain language. Ensuring all 

pages of the Form FDA 2289 are issued. 

ix. Informing the owner, operator, or agent in charge of the place 

where the drug is located that the drug is being administratively 

detained and that he or she has an opportunity to appeal and have 

a hearing on the detention.

x. Informing the owner, operator, or agent in charge of the 
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establishment where the drug is detained of his or her responsibility 

to establish and maintain records as required by 21 CFR 1.980(k) 

at the time the FDA official issues the detention order, or as soon 

as possible thereafter.

xi. Notifying the senior compliance official, or designee, of the 

appropriate Center, Director of OSPOP/DE, and OCC by phone or 

e-mail that the order has been issued and supplying them with a 

copy of the detention order and a copy of any supporting 

information, e.g., FDA Form 483, by the most expeditious means 

available (loading scanned copies into CMS, fax, express mail, email, etc.) immediately after issuance. Coordinate with OSPOP/DE 

to ensure that an appropriate presiding officer is identified.

xii. Notifying the ORA Office of Pharmaceutical Quality Operations 

Program Director that the Division Director issued a detention 

order. However, the Program Director should not become involved 

in decisions relating to issuing or monitoring the detention order. 

The Program Director may be the presiding officer who decides any 

appeal of the detention order, and consequently, this individual 

must avoid participating in the investigation or action that is the 

subject of the detention order and to remain free from bias or 

prejudice (21 CFR 16.42(b)). 

xiii. If CMS is not used for initial notification, loading copies of all 

related documents into CMS within a reasonable time.

xiv. Expediting the preparation and processing of a seizure 

recommendation involving the detained drug. The Division should 

flag the recommendation to indicate that it involves a detained drug 

and show the date the detention expires and should forward the 

recommendation to the responsible Center and notify the OCC 

Regional Litigation Senior Enforcement Advisor. by the most 

expeditious means available (loading scanned copy into CMS, fax, 

express mail, e-mail, etc.) immediately after completion.

xv. Approving and monitoring any permitted movement of the drug 

once FDA issues the detention order.

xvi. Monitoring regularly the relevant phone, e-mail, and fax 

machine in the issuing Division’s office, over weekends and 

holidays, for an appeal from any person that would be entitled to 

claim the drug had it been seized, unless the Program Division has 

no employees located in the Division office, in which case Division 

Office Personnel will monitor the fax machine.
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xvii. If the Division Director or Program Division receives any 

communications regarding the ADO from any person that would be 

entitled to claim the detained drug had it been seized, the Division 

must immediately notify the relevant parties in ORA OPQO, the 

Division, OCC, OSPOP/DE, Center Compliance, and the presiding 

officer. All communications should be uploaded into CMS.

xviii. Monitoring the length of the detention and the progress of 

the seizure recommendation, as well as extending the detention 

order from 20 to 30 calendar days if the order will expire prior to the 

agency or State initiating any appropriate legal action.

xix. Coordinating with OCC, the U.S. Attorney’s Office and the 

Marshal’s Service if a complaint for seizure is to be filed.

xx. Issuing a Detention Termination Notice (Form FDA 2291) in a 

timely manner.

b. Center Responsibilities - The Center is responsible for: 

i. Deciding whether to support the reasonable belief that the 

product is adulterated or misbranded at the time of the proposed 

detention. If the Center with jurisdiction over the product does not 

support the proposed detention, then the Division Director may not 

issue the order. Generally, a formal submission of documents 

supporting the detention is not necessary; rather, the Center the 

senior compliance official communicates his or her decision to the 

Division Director by phone, email, or other expedited 

communication.

ii. Coordinating Center case review with other Centers as 

necessary.

iii. Reviewing quickly any information provided by the Program 

Division, through OSPOP/DE, alerting the Program Division and 

OCC of any problems, and forwarding to the Program Division all 

requested documents.

iv. Providing expert testimony and other support, as appropriate.

v. Working with the Program Division Compliance Branch and OCC 

to identify evidence needed to support the legal case and appeal. 

vi. Promptly notifying the Program Division, OSPOP/DE, and OCC 

of any issues or Center concerns that need to be resolved, prior to 

providing support for the administrative detention and subsequent 
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enforcement action. 

vii. Coordinating the administrative detention and subsequent 

enforcement action with the Program Division, OSPOP/DE and 

OCC.

c. OSPOP/DE responsibilities –OSPOP, Division of Enforcement is 

responsible for:

i. Ensuring that the Center and OCC have received copies of the 

detention order, any appeal (with or without a request for hearing), 

and other supporting documents. OSPOP/DE will coordinate the 

detention to ensure that all appropriate FDA components have 

received notification and are preparing for a hearing in a timely 

manner.

ii. Designating the appropriate Presiding Officer should a hearing 

be necessary and ensure the Presiding Officer is in contact with 

designated attorneys from OCC to assist with the hearing process.

iii. Coordinating location for the conduct of a hearing as necessary.

iv. Obtaining transcription services to document the hearing as 

necessary.

v. Coordinate the administrative detention and subsequent 

enforcement action with the Program Division, the appropriate 

Center, and OCC. For example, OSPOP/DE enlists the support of 

the presiding officer, alerts ACRA, and assures that legal 

representation is available to the Division/Center and the presiding 

officer.

d. OCC Responsibilities – The Office of Chief Counsel is responsible for:

i. Reviewing quickly any information provided by the Program 

Division, including the proposed detention order, and, through 

OSPOP/DE, alerting the Program Division, Division Director, and 

the Center’s senior compliance officials and OSPOP of any 

problems prior to the detention being put in place.

ii. Beginning preliminary preparations for any appeal. The 

appropriate Deputy Chief Counsel for Litigation shall make staff 

assignments in OCC and notify the Program Division of the 

attorneys assigned to the case. The Principal Deputy Chief 

Counsel shall make staff assignments in OCC for the presiding 

officer.
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iii. Providing litigation support for any subsequent Agency 

enforcement action. 

e. ORA Office of Pharmaceutical Quality Operations Program Director 

Responsibilities –

i. Acting as a presiding officer, unless he or she removes himself or 

herself or is unavailable (21 CFR 1.980(g)(4), 21 CFR 16.40 and 

16.42).

ii. Insulating himself or herself from all aspects of a detention 

except those relating to his/her responsibilities as a presiding 

officer.

5-5-4 Appeal of a Detention Order

1. Appeal, With or Without an Informal Hearing

Under section 304(g) of the FD&C Act, any person who would be entitled to 

claim the drug if it had been seized under section 304(a) of the FD&C Act, may 

appeal a detention order. The appeal must be submitted in writing, to the 

Division Director in whose Division the detained drug is located, at the mailing 

address, e-mail address, or fax number identified in the detention order. The 

appeal must include a statement by the appellant asserting an ownership or 

proprietary interest in the detained drug. If the detained drug is located at a 

place other than an establishment owned and operated by the appellant, the 

appellant must include documents showing that the appellant would have 

legitimate authority to claim the drug if it had been seized.

If the detention order is appealed, the appellant has the right to request an 

informal hearing. The request for a hearing must be in writing and must conform 

to time frames. The presiding officer has the authority to deny a hearing, in 

whole or in part, when the appeal raises no genuine and substantial issue of 

fact and FDA is entitled to judgment as a matter of law. If the presiding officer, in 

consultation with OCC, determines that a hearing is not justified, the presiding 

officer will issue written notice of that determination and provide it to all parties 

explaining the reason for denial. 21 CFR 16.26(a). See Exhibit 5-25 for Model 

letter denying a hearing.

If granted, the informal hearing will be conducted in accordance with 21 CFR 

Part 16, except where modified by 21 CFR 1.980(g)(3) or as waived by the 

presiding officer under 21 CFR 16.60(h), as appropriate. See Exhibit 5-24 for 

Model letter granting a hearing.

2. Time Frames 
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The regulation allows an appellant 5 working days from receipt of the detention 

order (which also serves as notice of opportunity for a hearing) to appeal the 

detention, with or without a request for an informal hearing. The appeal must be 

in writing, must be addressed to the Division Director in whose Division the 

detained goods are located, and must contain a statement asserting an 

ownership or proprietary interest in the detained drug that would qualify the 

appellant to claim the drug if it had been seized. FDA will file the appeal on the 

day the appeal is received. 

If the appellant does not request an informal hearing, the decision to affirm or 

revoke the detention must be rendered within 5 working days after the Division 

receives the appeal. 

If the appellant does request a hearing, then the appellant must indicate 

whether the hearing is requested to be held within 5 working days after the 

appeal is received (an immediate hearing) or at a later date, but not later than 

20 calendar days after the detention order was received (a delayed hearing). 

When the appellant requests an immediate hearing, then the presiding officer 

holds the hearing and renders his/her decision within 5 working days after the 

date the appeal was filed. When the appellant requests a delayed hearing, the 

presiding officer schedules the hearing for no later than 20 calendar days after 

the detention order was received and issues his/her decision within 5 working 

days after the hearing concludes. If the appellant requests a delayed hearing, 

the presiding officer still must endeavor to conduct the hearing and issue his or 

her decision within 30 calendar days of the detention order being issued.

Presiding Officer Responsibilities – The presiding officer is responsible for: 

1) Determining whether to grant or deny an appeal with or without an 

informal hearing request from the appellant in accordance with 21 CFR 

1.980 and, as applicable, 21 CFR part 16. Any person who would be 

entitled to claim the drug if seized under section 304(a) of the FD&C Act, 

may appeal a detention order and may request an informal hearing as 

specified in 21 CFR 1.980.

2) If an appeal with a hearing is requested, determining whether the 

appellant has raised a genuine and substantial issue of fact justifying a 

hearing on the administrative detention order (21 CFR 16.26(a)), and if 

not, denying the request for an informal hearing, in whole or in part. If the 

hearing is denied, the presiding officer must still issue a decision to revoke 

or affirm the detention order (i.e., whether the investigator had reason to 

believe the drugs were adulterated or misbranded at the time of the 

detention).
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3) If there is an appeal, but no hearing is requested, determining 

whether the investigator had reason to believe the drugs were adulterated 

or misbranded at the time of the detention, i.e. affirming or revoking the 

detention order. 21 CFR 1.980(g)(7).

4) Determining whether to waive, modify, or suspend any provision 

under 21 CFR part 16 as authorized by 21 CFR 10.19 and 21 CFR 

16.60(h).

5) See section 5-3-4 item # 5(b) below for further responsibilities of 

the presiding officer.

4. Communications Between Parties to the Hearing and the Presiding Officer

Parties to the hearing should avoid any off-the-record communication with the 

presiding officer. If any communication of this type occurs, it must be 

documented in writing and made part of the administrative record of the hearing. 

The other party must be provided with a copy of the letter or memorandum of 

the communication and must be provided an opportunity to respond (21 CFR 

16.44(b)).

The person who writes a letter or memorandum of the meeting between a 

participant in the hearing and the presiding officer must send a copy to all the 

participants (21 CFR 16.44(c)).

5. Appeal Processing Responsibilities

a. Program Division Responsibilities 

The Program Division should begin preparing for an appeal at the time it 

decides to detain a drug, because a potential claimant to the detained 

drugs may request an immediate hearing. 

i. When the Division Director receives an appeal, the Division 

Director, or the Program Division acting at the direction of the 

Division Director: 

Date and time stamp the appeal and notifies the appellant in writing 

that it has received the appeal. If the appeal does not demonstrate 

an ownership or proprietary interest as required in 21 CFR 

1.980(g)(1) and (2), contact the appellant and clarify this 

information. The appellant must submit any missing information to 

the Division Director in writing.

Immediately notifies, orally or by email, the Center, OSPOP/DE, 

OCC, and the presiding officer of the appeal, and forwards a copy 

of the appeal to them as soon as possible by fax or electronically. 
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Requests assistance of the Center, OSPOP/DE, and OCC as 

needed. OCC will designate attorneys to advise the Program 

Division, Center, and presiding officer. 

ii. When the appeal includes a request for a hearing, the 

Division Director, or the Program Division acting at the direction of 

the Division Director: 

Prepares a general summary of the information that will be 

presented by FDA at the hearing in support of the detention order 

(“general summary”) and a comprehensive statement of the basis 

for the detention order (“comprehensive statement”), in accordance 

with 21 CFR 16.24(f). The detention order may serve as the 

comprehensive statement only if the reason for detention is 

described in sufficient detail. 

Forwards the general summary and the comprehensive statement 

to the appellant (21 CFR 16.24(f)), the presiding officer, and the 

Center, OSPOP/DE, and OCC representatives. The Program 

Division sends the documents immediately to all parties so that 

they arrive as soon as possible, but at least one day prior to the 

hearing. 

At least one day before the hearing, provides the appellant, 

presiding officer, and the Center, OSPOP/DE, and OCC 

representatives to the hearing, written notice of any published 

articles or written information to be presented at or relied upon at 

the hearing. A copy will also be provided in advance if the other 

participants could not reasonably be expected to have or be able to 

obtain a copy. If written notice or a copy is not provided, the 

presiding officer may, if time permits, allow the party who did not

receive the notice or copy additional time after the close of the 

hearing to make a submission concerning the article or information. 

(21 CFR 16.24(g)). 

iii. When the appeal does not include a request for a hearing, 

the Division Director, or the Program Division acting at the direction 

of the Division Director:

Forwards all the information that supports the detention to the 

presiding officer and all OCC attorneys participating in the appeal. 

This includes the general summary and comprehensive statement 

and any additional information provided by the appellant. The 

information is expected to arrive within sufficient time for the 

presiding officer to render a decision on the appeal, affirming or 

revoking the detention, within 5 working days after the filing of the 
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appeal. 

b. Presiding Officer Responsibilities 

i. When notified of an appeal, with or without a request for 

hearing, the presiding officer: 

Determines whether the appeal is valid because the appeal has 

been submitted within the established time frame or if the appeal 

demonstrates ownership or proprietary interest as required in 21 

CFR 1.980(g)(1), (2). 

ii. When notified of an appeal, and a hearing is requested, the 

presiding officer: 

Determines whether a hearing should be granted in whole or in 

part. A hearing will only be granted if the material submitted by the 

appellant raises a genuine and substantial issue of fact (21 CFR 

16.26(a)). A hearing will not be granted on matters of law or policy. 

See Exhibit 5-24 Model Letter Granting a Hearing. 

If the presiding officer denies a hearing, the presiding officer notifies 

the appellant of the hearing denial in writing. See Exhibit 5-25 for 

an example of a model letter denying an appellant’s request for a 

hearing. 

If the presiding officer grants a hearing, the presiding officer orally 

contacts the parties as soon as possible to set a hearing date. 

Depending on whether the appellant selected an immediate or 

delayed hearing, the presiding officer will set a hearing date and 

time to allow for a decision with the time frames. If practicable, a 

hearing may be conducted via teleconference or video conference. 

Provides all parties with written notification of the time, date, and 

location of the hearing. The hearing normally takes place at the 

Division Office in the geographic Division where the detained drugs 

are located.

Provides the appellant with oral and written notification of the 

following:

Notification of those portions of 21 CFR Part 16 that are 

excluded or modified under 21 CFR 1.980(g)(3) and waived 

or modified for hearings on appeal of administrative 

detentions (see "5-X-5"). 
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Notification whether the informal hearing is to be public or

not per 21 CFR 16.60(a). The Commissioner, or other official 

with delegated authority, determines whether all or part of a 

hearing should be closed to prevent a clearly unwarranted 

invasion of personal privacy; to prevent the disclosure of a 

trade secret or confidential commercial or financial 

information that is not available for public disclosure under 

20.61; or to protect investigatory records complied compiled 

for law enforcement purposes that are not available for 

public disclosure under 20.64.

Notification that the appellant should briefly summarize at 

the hearing any lengthy documents that they are presenting 

(e.g., voluminous computer printouts). 

Notification that, if feasible, the appellant should provide the 

Division Director, at least 1 day before the hearing, written 

notice of, or a copy of (if the Division Director could not 

reasonably be expected to have or be able to obtain a copy), 

any published articles or written information that appellant 

intends to present or rely upon at the hearing, as required by 

21 CFR 16.24(g). 

Notification of the requirements under 21 CFR 16.44(c) (see 

"Communications Between Parties to the Hearing and the 

Presiding Officer"). 

iii. When there is an appeal, and no hearing is requested, the 

presiding officer is responsible for:

Immediately notifying the parties orally to submit information 

supporting their positions as soon as possible so that the 

information can be reviewed, and a decision reached within 5 

working days after the appeal was received. 

Orally notifying the appellant orally or in writing of the requirement 

under 21 CFR 16.44(c) (see “Communication Between Parties to 

the Hearing and the Presiding Officer”). 

c. OCC Responsibilities – The Office of Chief Counsel is responsible 

for all of the following:

i. Assigning OCC attorney(s) to represent advise the Division 

during any appeal and hearing. 

ii. Assigning different OCC attorney(s) to represent the 
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presiding officer during any appeal and hearing.

iii. Expediting review of information provided by the Division (or 

presiding officer, depending on whom OCC is supporting).

iv. Working with the Division (or presiding officer, depending on 

whom OCC is supporting) to prepare for any hearing and appeal. 

d. Center Responsibilities - The Center is responsible for providing:

i. Scientific, technical, and policy support to the Division. 

ii. Subject Matter Expert Witnesses at the hearing, if 

necessary. 

e. Division of Enforcement (DE) Responsibilities - Division of 

Enforcement is responsible for ensuring that all: 

i. All relevant FDA components are notified of and prepared for 

a hearing; and 

ii. Documentation from the Division Director and/or the 

Program Division relating to the detention and hearing is provided 

to the Center’s senior compliance official and OCC.

5-5-5 Informal Hearing on Appeal of a Detention Order

1. Background

Section 304(g) of the FD&C Act requires FDA to provide the appellant with an 

opportunity for an appeal including an "informal hearing,” as defined in 201(x) of 

the FD&C Act. 21 CFR 1.980(g)(3) requires that FDA conduct the hearing in 

accordance with 21 CFR part 16, Regulatory Hearing before the Food and Drug 

Administration, with certain limited exceptions noted below. 21 CFR 16.5(b) 

advises that part 16 procedures apply to the extent that they are supplementary 

to, and not in conflict with, the other procedures specified in a regulation, in this 

case 21 CFR 1.980, that provides a person with an opportunity for a hearing and 

specifies some procedures for the hearing, but not a comprehensive set of 

procedures. Further, 21 CFR 10.19 and 21 CFR 16.60(h) give the presiding 

officer the general authority to suspend, modify, or waive provisions under part 

16. 

According to 21 CFR 1.980(g), the presiding officer must be the ORA Program 

Director or another senior official above Division Director. DE is responsible to 

ensuring a presiding officer is assigned.
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Modifications to procedural requirements in 21 CFR Part 16

The presiding officer must conduct the hearing in accordance with 21 CFR part 

16, except the following sections of 21 CFR 16, as detailed in 21 CFR 

1.980(g)(3): 

a. §16.22(a). Under 21 CFR 1.980(d), the detention order provides notice of 

the opportunity for the hearing, rather than the notice under 21 CFR 

16.22(a), and the detention order is part of the administrative record of the 

regulatory hearing under 21 CFR 16.80(a). 

b. §16.22(b). Under 21 CFR 1.980(g)(3)(ii), a request for a hearing must be 

addressed to the FDA Division Director in whose Division the detained 

drug is located. 

c. §16.24(e). The hearing may be held within 2 working days after the request 

for hearing is received. The last sentence in 21 CFR 16.24(e), stating that 

a hearing may not be required to be held at a time less than 2 working 

days after the request for hearing is received does not apply to a hearing 

under this section. §16.42(a).

d. §16.42(a). 21 CFR 1.980(g)(4), rather than §16.42(a), notes that that ORA 

Program Directors or other FDA officials senior to an FDA Division 

Director may preside at hearings under this section.

After making the requisite findings under 21 CFR 10.19, the presiding officer has 

the authority to waive, suspend, or modify any of the other provisions in 21 CFR 

part 16. 21 CFR 16.60(h). In conducting a hearing under this section, the 

presiding officer should also waive the following other provisions, if appropriate: 

a. §16.60(f), which requires the presiding officer to include as part of the 

report of the hearing: a finding on the credibility of witnesses (other than 

expert witnesses) whenever credibility is a material issue; and a proposed 

decision, with a statement of reasons. 

b. §16.95(b)(1) & (2) states that the Administrative Record of a Regulatory 

Hearing (21 CFR 16.80(a)(1)-(5)) is the exclusive record and basis for the 

decision. These provisions may be modified as follows: the presiding 

officer bases the decision, in most cases, on all information presented to 

him or her prior to or during the hearing. The decision is not to be based 

on the following information or documents, if they are not received or 

completed by the presiding officer prior to the end of the hearing as 

required by the FD&C Act and its implementing regulations: 

i. Information and views submitted to the presiding officer after the 

hearing are not part of the official record unless the presiding officer 

permits post-hearing submissions and the information is submitted 

within the period specified by the presiding officer (21 CFR 

16.80(a)(2)). 

ii. Any transcript of the hearing (21 CFR 16.80(a)(3)). 

iii. The presiding officer's report of the hearing and comments on the 
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report under 21 CFR 16.60(e) and 16.80(a)(4).

In addition, the presiding officer may, if appropriate, waive the part of 21 CFR 

16.60(b) providing that all parties may confront and conduct reasonable crossexamination of any person (except for the presiding officer and counsel for the 

parties) who makes any statement on the matter at the hearing. See 21 CFR 

16.5 and 16.60(h).

2. Conducting the Hearing

At the start, the presiding officer reminds the parties of the applicable 

modifications under 1.980(g)(3), to 21 CFR part 16 “Regulatory Hearing Before 

the Food and Drug Administration.” The presiding officer explains that the 

purpose of the hearing is to determine whether the FDA investigator, at the time 

of the detention and as set forth in the detention order, had reason to believe that 

the drug was adulterated or misbranded. The issue is not whether the drugs are 

actually adulterated or misbranded. That question is properly left to the Division 

Court in any subsequent enforcement action. 

The FDA representative(s) is/are present to explain the basis for the detention 

and answer reasonable questions from the appellant.

The appellant then presents relevant information to support his/her position that 

the drug should not be subject to detention.

The presiding officer will ensure that the material presented, and the questions 

asked are relevant to the issue of the hearing and reasonable.

The presiding officer may, once the hearing commences, issue a summary 

decision on any issue in the hearing, if the presiding officer determines from the 

material submitted in connection with the hearing, or from matters officially 

noticed, that there is no genuine and substantial issue of fact respecting that 

issue (21 CFR 16.26(b)). 

The appellant may request that the hearing be transcribed. However, the 

appellant must pay the cost of having the hearing transcribed and furnish FDA a 

copy for the record. FDA also may request a transcript of the hearing, in which 

case the costs are borne by the agency.

The presiding officer should notify the parties that his/her decision will not await 

transcription or any correction of the transcripts that is ordered.

3. Responsibilities For The Hearing:

a. Center Responsibilities -
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The Center will provide documents, Subject Matter Expert witnesses, and 

office representatives for the hearing if requested by the Program Division 

and/or the OCC attorney representing the Program Division. 

b. OCC Responsibilities -

OCC will provide counsel for the Program Division and the presiding 

officer, as appropriate, for the hearing. 

c. Program Division and Presiding Officer Responsibilities -

Section 5-5-5, item # 2 “Conducting the Hearing” includes responsibilities 

of the Program Division and the presiding officer. The Program Division 

is responsible for assigning a Compliance Officer who has not previously 

been involved in the case to provide regulatory background and 

administrative assistance to the Presiding Officer. 

5-5-6 Issuing the Decision on an Appeal

1. Decision on an Appeal When Appellant Does Not Request a Hearing

If there is an appeal of the detention order, but the appellant does not request a 

hearing, the presiding officer must render a decision on the appeal, affirming or 

revoking the detention, within 5 working days after the appeal has been filed. The 

rationale behind the decision made should be documented in the record under 21 

CFR 1.980(g)(7). 

2. Decision on an Appeal after a Hearing

The appellant has the option of selecting an immediate or delayed hearing. If the 

appellant requests an immediate hearing (within 5 working days after the appeal 

is received), then the presiding officer must hold the hearing and render a 

decision affirming or revoking the detention within 5 working days after the 

appeal was received (21 CFR 1.980(g)(5)). In contrast, if the appellant requests a 

hearing be held later than 5 working days after the appeal was filed, but not more 

than 20 calendar days after the detention order issued, then the presiding officer 

must hold the hearing on an agreed-upon date and decide whether to affirm or 

revoke the detention order within 5 working days after the hearing closes (21 

CFR 1.980(g)(6)). The detention may not be extended past the otherwise 

applicable 30-day period.

3. Basis for Rendering a Decision

If the presiding officer determines that the investigator had reason to believe that 

the drug was adulterated or misbranded at the time of the detention under one or 

more of the bases set forth in the detention order, the presiding officer will affirm 
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the detention order. If there was no reason to believe the drugs were adulterated 

or misbranded, the presiding officer will revoke the detention order.

4. Issuance of the Order

The presiding officer issues the decision in the form of an order. (See Exhibit 5-

26 for model order confirming detention and Exhibit 5-27 for a model order 

revoking the detention.) The parties to the appeal should be orally notified of the 

order immediately. Copies of the order should then be mailed to the parties via 

overnight delivery with documented return receipt.

The presiding officer must render his/her decision on the detention within the 

time frames listed previously. The presiding officer cannot delay his/her order 

pending completion of a written decision and any report of the hearing (discussed 

subsequently). When possible, the presiding officer’s order should be issued at 

the same time as the written decision and any report of the hearing. However, in 

cases where the presiding officer needs additional time to complete the written

decision and any report of the hearing, the written order may issue first, and the 

written decision may issue separately from and shortly thereafter the order. All 

parties involved should receive a copy of both the written order and the written 

decision.

5. Written Decision and Report of Hearing

The presiding officer must prepare a written decision report that includes the 

reasons and bases for his or her order (§ 16.95(b)(2)). The written decision must 

include any report of the hearing required under 21 CFR 16.60(e), if applicable. 

All written material submitted during the hearing and any report of the hearing 

must be attached to the written decision (21 CFR 16.60(e)). Any transcripts of the 

hearing should be included, if available.

Whenever time permits, the participants will be given the opportunity to review 

and comment on the written decision and report of the hearing. However, the 

presiding officer should set a time limit for the participants to comment. (As 

previously noted, whenever possible, the written decision and report of the 

hearing should be issued with the order as a single document). 

5-5-7 Administrative Record and FOIA Requests

1. Administrative Record of Appeal without a Hearing

The presiding officer must prepare the administrative record of the appeal, which 

consists of the following:

a. The detention order and the appeal.

b. All written information submitted to the presiding officer in conjunction with the 
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appeal. 

c. All letters and memoranda of meetings and communications between 

participants and the presiding officer referred to in 21 CFR 16.44(c). 

d. The presiding officer’s order and written decision.

2. Administrative Record of Appeal with Hearing

The presiding officer must prepare the administrative record of the hearing, which 

consists of the following:

a. The detention order and the appeal.

b. All written information submitted to the presiding officer in conjunction with the 

appeal and hearing. 

c. Any transcript of the hearing, if available. 

d. All letters and memoranda of meetings and communications between 

participants and the presiding officer referred to in 21 CFR 16.44(c). 

e. The presiding officer’s written decision, report of the hearing, order, and any 

comments or written decision or report of the hearing permitted under Section 

201(x) of the FD&C Act and 21 CFR 16.60(e).

The presiding officer will forward the completed original administrative record to the 

Program Division Director. The Program Division will ensure storage of the original 

Administrative Record, with the firm’s official file at the Division office after 

completion of the report. The Program Division will ensure that an electronic copy is 

uploaded into the CMS Case and is distributed to the Division Director, OCC, 

OSPOP/DE, the Center, and the ORA Office of Pharmaceutical Quality Operations

3. FOIA Requests

21 CFR part 20 applies to all requests for the administrative record and other 

documents relating to administrative detentions. 

5-6 ADMINISTRATIVE DETENTION OF DEVICES

5-6-1 Purpose

This section provides the procedures and defines responsibilities for the Administrative

Detention of Devices.

5-6-2 Detention of Devices

1. Background

Section 304(g) of the Act authorizes the FDA to detain devices intended for 

human use for a period of up to thirty (30) calendar days if, during an inspection, 

the FDA has reason to believe the devices are adulterated or misbranded. The 

intent of administrative detention is to protect the public by preventing 
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distribution or use of violative devices until FDA has had time to consider the 

appropriate action to take and, where appropriate, to initiate a regulatory action. 

The action of choice, in most cases, is a seizure. Detention of devices requires 

prior approval from the division director in which the devices are located and the 

concurrence of the appropriate center‘s director for compliance.

Any person entitled to claim the devices, if seizure occurred, may appeal the 

detention and may request a hearing on the appeal. The decision to affirm or 

revoke the detention must occur within five (5) working days of receipt of the 

appeal if there is no request for a hearing or if the request for a hearing is within 

five (5) working days after filing the appeal. If requesting the hearing for a date 

more than 5 working days after receiving the appeal, the decision must occur 

within five (5) working days after the conclusion of the hearing.

The Center for Biologics Evaluation and Research (CBER), the Center for Drug 

Evaluation and Research (CDER), and the Center for Devices and Radiological 

Health (CDRH) are responsible for administering the medical device 

amendments. See 21 CFR Part 3.

2. References

The regulatory authority for administrative detention and associated operations 

appears in Sections 304(g) and 201(x) of the Act, and in 21 CFR 800.55, 21 

CFR Part 16, 21 CFR 5.47, and 21 CFR 10.19. The IOM Chapter 2, Subchapter 

2.7, Detention Activities contains the instructions for implementing the detention 

authority.

3. Detention Procedure

This enforcement tool should be considered when there is likelihood that the 

device(s) will be moved or distributed before seizure can be accomplished.

Whenever possible, state embargoes should be used instead of administrative 

detention because the latter can be resource intensive.

If the division director concludes that the person in possession of the device(s) 

will voluntarily hold the product, will provide assurance that integrity and security 

will be maintained over the devices on hand, and agrees to correct the 

violation(s) prior to shipment, there is no need to detain the goods.

At a minimum, prior to approving the detention order, the division director 

contacts the senior compliance official in the appropriate center to ensure that 

the Agency supports an administrative detention based on the violations 

observed. This ensures that the Agency considers recent developments or 

changes not yet communicated to the division. In addition, the division director 

notifies headquarters of the impending seizure recommendation. Contacts are:
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For a conventional medical device:

Director, Office of Compliance (HFZ-300), CDRH 

(301) 796-5500 

or, for a biological device:

Director, Office of Compliance and Biologics Quality (HFM-600), CBER 

240-402-9153. 

Concurrence is by telephone. The division or headquarters does not require 

written concurrence except for cause, for example, for issues of science, 

policy, or law involving precedent or questionable facts.

a. Approval of Detention Order By The Division Director

The division director approves a detention order, before issuance, either 

orally or in writing. If the approval is oral, it should be placed in writing as 

soon as possible.

b. Detention Order Issuance

An investigator or other authorized agent signs the order. Issue the order in 

writing to the owner, operator, agent, or other responsible person in charge 

of the place where the device is located.

When issuing the order, the FDA investigator informs the owner, agent or 

other responsible person that they have the opportunity to appeal and have 

a hearing on the detention as noted on the order. If the order is not issued to 

the owner or agent of the owner of the device, then the division sends, as 

soon as possible, copies of the detention order and 21 CFR 800.55(g)(1) &

(2) to the owner, via certified mail return receipt requested.

c. Form of Order

Issue the detention order on Form FDA 2289 Detention Notice.

Section 2.7.2.3 of the IOM contains instructions for completion of the form.

The detention order frames the issues for appeal or informal hearing, which 

may result from the detention. Therefore, the information on the order 

concerning the reason for detention is very important.

There is no requirement that the order include all of the reasons for 

believing that the product is adulterated or misbranded. Only list the more 

significant violations. However, if a violation is not identified in the order, it 

may not be relied on to support the detention. State the charge in the order 

in factual, non-statutory language. For example, if the investigator finds a 

sterile, individually packaged syringe with holes along the seams of the 
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packaging, black greasy spots on the needle, and the label lacks the Zip 

Code of the manufacturer, describe the apparent violation in the reason for 

detention as "there is reason to believe the device is:

Adulterated per Section 501(a)(2)(A) of the Act because there are holes in 

the package and black spots on the needles. The firm prepared, packed, or 

held the product under insanitary conditions whereby it may have been 

rendered injurious to health.

Misbranded per Section 502(a) because the label states that it is sterile and 

the integrity of the package is compromised by holes. The labeling is false 

or misleading.”

Note: Use a "continuation sheet" if all of the charges will not fit on the form.

Note: Charges used in the detention order do not necessarily limit the 

charges that may be identified in a subsequent complaint filed in court. 

d. Length of Detention

According to statute, a detention is for twenty (20) calendar days unless the 

division believes that additional time is required to accomplish a legal action. 

In such cases, the detention is for thirty (30) calendar days at the time of 

issuing the order. When extending a detention from twenty (20) to thirty (30)

days, issue another detention order and place new tags on the devices.

By statute, the detention cannot last for longer than thirty (30) calendar 

days.

e. Movement, Use, etc. of Detained Devices

Except as noted below, without the written permission of the Agency, 

detained devices cannot be moved, used, altered, or tampered with in any 

manner. Therefore, if possible, the investigator should segregate the 

detained devices from other devices or products at the time of the detention,

so they remain undisturbed.

With the approval of the division director, the investigator who detained the 

devices or any other responsible division official may authorize, in writing, 

the movement of detained material. Whoever moves the devices must 

immediately notify (orally) the authorizing official of the new location.

The only exception to the prohibition on movement without written 

permission is when the goods are not in final form for shipment and the 

manufacturer wants to complete work on them. The manufacturer may 

move them within the facility where detained to complete manufacture but
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must orally notify FDA of the movement as it occurs. When completing 

manufacturing, the manufacturer must immediately segregate the detained 

devices from other products and orally notify FDA of their new location.

However, the manufacturer may not move the devices from the 

establishment without prior written approval of the division director as 

referenced above.

Note: 21 CFR 800.55(h)(2) prohibits further movement even within the 

establishment without FDA approval.

f. Legal Actions Against Detained Devices

The division should expedite the preparation and processing of a seizure 

recommendation involving the detained devices. The recommendation 

should be flagged to indicate that it involves detained devices and show the 

date the detention expires and should be forwarded to the responsible 

center by overnight delivery service.

The center compliance office, ORA, and OCC should likewise expedite their 

reviews to accomplish the legal action prior to expiration of the detention. If 

the move the goods and the violative product may find its way into 

commercial distribution.

The division is responsible for monitoring the length of the detention and the 

progress of the recommendation. If a twenty (20)-day detention expires prior 

to accomplishing the legal action, the division should extend the detention 

for an additional ten (10) days.

The division is responsible for coordination with the U.S. Attorney's office 

and the Marshal's Service, ensuring prompt filing of the complaint, and 

seizure of the goods.

The division is also responsible for immediately providing oral notice to the 

appropriate center compliance office, OCC, and the presiding officer of the 

accomplishment of the seizure or of any appeal of a detention order.

g. Recordkeeping Requirements

At the time of issuance of a detention order, or as soon as possible 

thereafter, the division informs the owner, operator, or agent in charge of the 

establishment where the devices are detained of their responsibility to 

establish and maintain records as required by 21 CFR 800.55(k).
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h. Termination of Detention Orders

i. The reasons for termination of Detention orders:

• FDA determines that the device(s) is (are) not violative.

• FDA approves voluntary destruction or compliance by reconditioning or 

other means (e.g., relabeling).

• FDA revokes the detention on appeal.

• FDA accomplishes a regulatory action against the product. Actual 

seizure or entry of TRO or an order by consent or otherwise of 

preliminary injunction is necessary. The filing of a complaint does not 

necessarily terminate a detention order.

• The detention period expires.

The division director, within whose division the devices are detained, must 

approve termination of detention orders. Approval is oral or written, and if oral, 

confirmation is in writing. The division issues the Detention Termination Notice 

(Form FDA 2291) to the person(s) who received the Detention Notice, or his 

representative and, if movement of the devices occurred prior to the 

termination, to the person possessing the devices. Issuance of the notice is in 

person or by mail. If the termination notice is issued by mail, request that the 

Detention Tags (Form FDA 2290) be returned. If the termination notice is 

issued in person, see IOM 2.7.2.5 for advising the owners, operators, or agents 

in charge to keep the records concerning the detention for the remainder of the 

two year period from the date of detention or such shorter period as FDA 

directs.

4. Responsibilities for Issuing and Terminating Detention Orders

a. Division Responsibilities As referenced above, the division is responsible for:

i. Ensuring support from the senior compliance official of the appropriate 

center before issuing a detention order.

ii. Issuing the detention order.

iii. Notifying the Director of the Division of Enforcement (DE) by phone of 

the detention and supplying that person with a copy of the detention 

order by the most expeditious means available (fax, express mail, etc.) 

immediately after issuance.

iv. Approving and monitoring the movement of detained devices.

v. Notifying OSPOP/DE and the program director that the division issued a 

detention order.

NOTE: Keep the Division Director insulated from detention proceedings 

after the detention is in place in order to avoid even the appearance of 

bias or prejudice.
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vi. Pursuing the follow-up legal action as discussed under the heading, 

"Legal Actions Against Detained Devices."

b. Center Compliance Office Responsibilities

Division contact with the center, for concurrence, is a routine procedure. If the 

director of compliance for the center will not support a proposed detention, do 

not issue the order. Communication of the director’s decision to the division is 

by phone, e-mail, or other expedited communication. Generally, a formal 

submission of documents supporting detention is not necessary.

The compliance office will quickly review any information provided by the 

division, through DE, alert the division, and OCC of any problems, and forward 

to the division all requested documents. The compliance office will provide 

expert witnesses and other support, as appropriate.

c. Office of Chief Counsel Responsibilities

OCC will quickly review any information provided by the division, and through 

DE, alert the division, the center office, of any problems, prior to the detention 

being put in place.

The Deputy CC for Litigation or the Deputy CC for Regulations and Hearings 

shall make staff assignments in OCC and notify the center and DE of the 

attorney assigned to the case. OCC will begin preliminary preparations for 

any appeal. OCC will determine whether the division and the program(s) 

require legal counsel.

d. DE Responsibilities

Upon notification that a detention has been affected or a subsequent appeal 

received by the division:

DE will immediately notify the center compliance office and OCC, and deliver 

to them copies of the detention order, request for hearing, and other 

supporting documents. DE will coordinate the detention to ensure that all 

Agency and OCC components receive notification and prepare for a hearing 

in a timely manner.

e. Division Responsibilities

The Division must insulate himself/herself, after the detention is in place, from 

all aspects of a detention except those relating to his/her responsibilities as a 

presiding officer. Responsibilities at that time are in the next section, "Appeal 

of a Detention Order."
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5-6-3 Appeal Of A Detention Order

1. General Information

a. Background

Section 304(g) of the Act permits anyone who is entitled to claim the 

goods, if seized, to appeal a detention order.

If appealing the detention, Section 304(g) requires that the Agency afford 

the appellant with an opportunity for an informal hearing. If the appellant 

does not request an informal hearing, the decision to affirm or revoke the 

detention must be rendered within five (5) working days after the filing of 

the appeal. The appellant may request the holding of an informal hearing 

either within five (5) working days after filing the appeal or at a later date, 

but not later than twenty (20) calendar days after receipt of the detention 

order. 21 CFR 800.55(g)(1). If the appellant requests a hearing within five 

(5) working days after filing the appeal, the presiding officer holds the 

hearing and renders a decision within five (5) working days of the filing of 

the appeal. In the event of a request for a delayed hearing, the scheduling 

of the hearing must occur after the fifth working day following the appeal, 

and a decision must be issued within five (5) working days of the hearing's 

conclusion.

Regardless of the scheduling of the hearing, there is no extension past the 

thirty (30)-calendar day detention period without the consent of the 

appellant. (The provision for extension of the detention found in 21 CFR 

800.55(g)(6) is incorrect and should not be followed.)

b. Time to Appeal

The regulations allow an appellant five (5) working days from the receipt of 

the detention order (which also serves as a notice of opportunity for a 

hearing) to appeal the detention, with or without a request for an informal 

hearing. The appeal must be in writing, must be addressed to the division

director of the division office within whose area the goods are detained, 

and must contain a statement asserting that interest (e.g., ownership) in 

the detained goods would qualify the appellant to claim the goods if they 

were to be seized. The postmark on the appeal letter will determine the 

date of the appeal.

The division director will allow one (1) day of additional time for the receipt 

of an appeal request. Allow additional time if the appellant shows that it

was impossible to appeal earlier.
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c. Presiding and Deciding Official

The director for the division where the division is located and in which the 

goods were detained must be the presiding and deciding official unless 

he/she disqualifies him/herself (21 CFR 800.55(g)(4), 21 CFR 16.40 and 

16.42, and 21 CFR 5.47). In the event of disqualification, the Division will 

immediately arrange for another Division to preside and provide 

immediate notification of any such change to the division director and the 

appellant.

Communications Between Parties to the Hearing And the Presiding Officer 

Avoid any off-the-record communication between parties to the hearing 

and the presiding officer. If any such communication occurs, reduce it to 

writing and make it a part of the record. The presiding officer must supply 

a copy of any memoranda of such communication, which would affect his 

or her decision, to the other party, giving them an opportunity to respond.

21 CFR 16.44(b).

The person who originates any written communication between a 

participant in the hearing and the presiding officer must send a copy of 

any such communication to all of the participants. 21 CFR 16.44(c).

2. Appeal Processing Responsibilities

a. Division Responsibilities

Preparation for an appeal should begin when the division decides to 

detain a device(s), in case a hearing is requested within five (5) working 

days of the filing of the appeal.

i. When the division receives an appeal, the director:

• Dates and time-stamps the appeal, and notifies the appellant of 

receipt of the appeal. If the appeal does not specify that a hearing 

is or is not requested, does not demonstrate ownership or 

proprietary interest as required in 21 CFR 800.55(g)(1) and (2), or 

does not specify the time period within which to hold a hearing (see 

“Appeal of a Detention Order- Background"), contact the appellant 

and clarify this information. Make any declaration of ownership or 

proprietary interest in writing.

• Orally notifies the Division and the Director, DE of the appeal

immediately and forwards a copy of the appeal to them as soon as 

possible. Requests assistance of OCC and the appropriate center 

for completing the next item.
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ii. When the appeal includes a request for a hearing:

• Prepare (1) a general summary of the information that the detention 

and (2) a comprehensive statement of the basis for the action. The 

Detention Order (notice) may serve as the comprehensive 

statement only if the reason for detention is described in sufficient 

detail. See Exhibits 5-14 and 5-15 for an example of a general 

summary and a comprehensive statement respectively. See Exhibit 

5-16 for examples of reasons detailed enough for the FDA 2289 to 

serve as a comprehensive statement.

• Forward the general summary and comprehensive statement to 

appellant (21 CFR 16.24 (f) and Section 201 (x)(3) of the Act, the 

Division, and any office and OCC representatives to the hearing. 

Send the documents immediately so that they arrive as soon as 

possible, but at least one (1) day prior to the hearing.

• At least one (1) day before the hearing, provide the appellant, the 

Division, and any office and OCC representatives to the hearing, 

written notice of, or copies or, if they could not reasonably be 

expected to obtain copies, and published articles or written 

information to be presented at or relied on at the hearing (21 CFR 

16.24 (g)). 

iii. When the appeal does not include a request for a hearing, the division

forwards all the information that supports the detention to the Division

acting as the deciding official. The division includes the referenced 

general summary and comprehensive statement and any additional 

information provided by the appellant. It must arrive within sufficient 

time to be reviewed and for a decision to be rendered within five (5)

working days after receipt of the appeal.

b. Presiding Division Responsibility

When notified of an appeal, the Division

i. If a hearing is requested,

• Orally contact the parties as soon as possible. Depending on the 

time period within which the appellant requests a hearing, either set 

a hearing date and time to allow for a decision within five (5)

working days after the date of receipt of the appeal by the division, 

or set a hearing date and time later than five (5) working days after 

receipt of the appeal by the division, but not later than twenty (20)

calendar days after issuance of the detention order. The hearing 

normally takes place at the division office where the goods are

located.
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• Provide all parties with written notification of the time, date, and 

location of the hearing.

• Provide the appellant with oral and written notification (see form 

letter as Exhibit 5-17) of the following:

ii. Notification of those portions of 21 CFR Part 16 that are excluded or 

modified under 21 CFR 800.55(g)(3) and waived or modified for 

hearings on appeal of administrative detentions. See subsection 5-5-4 

"Informal Hearing on Appeal of a Detention Order."

iii. Notification that the informal hearing is not a public hearing per 21 

CFR 16.60(a), in order to protect investigatory records compiled for 

law enforcement purposes that are not available for public disclosure 

under 21 CFR 20.64, or trade secret material under 21 CFR 20.61.

iv. Notification that the appellant should provide, at the hearing, a brief 

summary of any lengthy documents for presentation at the hearing 

(e.g., volumes of computer printouts).

v. Notification that if feasible, at least one (1) day before the hearing, the 

appellant should provide the division director written notice of, or a 

copy of (if the division director could not reasonably be expected to 

obtain a copy), any published articles or written information for 

presentation at or relied on at the hearing as required by 21 CFR

16.24(g).

vi. Notification of the requirements under 21 CFR 16.44(c) (see 

"Communications Between Parties to the Hearing and the Presiding 

Officer.")

vii. If an appeal is made but no hearing is requested, the presiding officer 

must immediately orally notify the parties to submit information 

supporting their positions as soon as possible so that the information 

can be reviewed, and a decision reached within five (5) working days 

of the receipt of the appeal. We will accept additional information 

submitted prior to the decision. The presiding officer orally notifies the 

appellant of the requirement under 21 CFR 16.44(c) (see 

"Communications Between Parties to the Hearing and the Presiding 

Officer.")

When advice of the CC is needed, contact the Deputy CC for Litigation.

5-6-4 Informal Hearing On Appeal Of A Detention Order

Section 304(g) of the Act states that upon appeal of a detention order, the Agency will 

afford the appellant with an opportunity for an "informal hearing." Section 201(x) of the 

Act defines an informal hearing and lists specific provisions. 21 CFR 800.55(g)(3) 

provides that 21 CFR Part 16, Regulatory Hearing, establishes the procedures for 

conducting the informal hearing. 21 CFR 16.5 of the regulations advises that Part 16
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procedures apply to the extent that they are supplementary to, and not in conflict with, 

other procedures specified for the hearing. 21 CFR 16.60(h) gives the presiding officer 

the power to suspend, modify, or waive provisions under Part 16.

1. Waivers, Modifications, Etc. To 21 CFR Part 16

21 CFR 800.55(g)(3) waives the following sections of 21 CFR Part 16:

a. §16.22(a) concerning the issuance of a separate notice of opportunity for 

hearing because the detention notice FDA 2289 serves that function 

under 21 CFR 800.55(g)(3)(i).

b. §16.22(b) concerning the forwarding of the appeal to the presiding officer 

because 21 CFR 800.55 (g)(1) requires sending the appeal to the division

director.

c. §16.24(e) concerning not permitting the hearing to be held within two (2)

days of the receipt of the appeal because time constraints cannot allow 

for such a restriction.

d. §16.42(a) regarding those persons who may act as the presiding officer 

because 21 CFR 800.55(g)(4) only allows Divisions to be presiding 

officers.

The presiding officer has the authority to waive, suspend, or modify any of the 

provisions under Part 16 (21 CFR 10.19 and 21 CFR 16.60(h)). The presiding 

officer must waive the following other provisions:

a. §16.60(f) which requires the hearing officer to make a recommended 

decision with statement of reasons to the deciding official because the 

Division performs both functions.

b. §16.95(b)(1) & (2) which state that the Administrative Record of a 

Regulatory Hearing (21 CFR 16.80(a)(1)-(5)) is the exclusive record and 

basis for the decision, are modified as follows: FDA bases the decision, in 

most cases, on all information presented to the presiding officer prior to 

or during the hearing. The decision is not to be based on the following 

information or documents, if they are not received or completed by the 

presiding officer within the time necessary for the presiding officer to 

review or complete them prior to making the decision as required by the 

Act or regulation:

i. Information and views submitted to the presiding officer after the 

hearing are not part of the official record unless the presiding 

officer permits post- hearing submissions and submittal of 

information occurs within the period specified by the presiding 

officer (21 CFR 16.80(a)(2)).

ii. Any transcript of the hearing (21 CFR 16.80(a)(3)).
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iii. The presiding officer's report of the hearing and comments on the 

report under 21 CFR 16.60(e) and 16.80(a)(4).

FDA waives that part of 21 CFR 16.60(b) which provides that all parties may 

confront and conduct reasonable cross-examination of any person (except for the 

presiding officer and counsel for the parties) who makes any statement on the 

matter at the hearing. There is an allowance for reasonable questions instead. 

Reference Congressional intent: House of Representatives Report no. 94-853. 

Also, see 21 CFR 16.5 and 16.60(h).

2. Responsibilities for the Hearing

a. Center Responsibilities

The center will provide documents, witnesses, or office representatives for 

the hearing if requested by the division or the OCC attorney counseling the 

division.

b. Office Of Chief Counsel Responsibilities

OCC will provide for the division and/or the presiding officer, as appropriate, 

for the hearing.

c. Division And Presiding Division Responsibilities

The section “Conducting the Hearing” includes individual responsibilities of 

the division and the presiding Division.

3. Conducting The Hearing – General Procedures/Responsibilities

At the onset, the presiding officer reminds the parties of the modifications to Part 

16 that apply and explain the purpose or issue of the hearing. The issue at the 

hearing is whether FDA had reason to believe the devices were adulterated or 

misbranded at the time of the detention and as charged in the detention order. 

The issue is not whether the law has been violated. That question is properly left 

to the court trial, if one is held.

The FDA representative(s) is present to explain the bases for the detention and 

answer reasonable questions from the appellant.

The appellant then presents relevant information and reasons why he believes 

the Agency did not have reason to detain the product.

The FDA representatives may then ask reasonable questions (see Section 

201(x)(4) of the Act).
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The presiding officer ensures that the material presented, and the questions 

asked are relevant to the issue of the hearing.

The appellant may request a transcript of the hearing. However, the appellant 

must pay the cost of it and furnish the presiding officer a copy for the record. 

The Agency can also request a transcript of the hearing and the costs are borne 

by the government.

If the appellant wishes a copy of the government transcript, he/she may obtain it 

via a Freedom of Information (FOI) Act request. 21 CFR Part 20 applies to the 

release of the transcript.

The presiding officer notifies the parties that his decision will not await 

transcription or correction of the transcripts so ordered.

5-6-5 Requirements After A Hearing On Appeal Of A Detention Order

1. Presiding Division Responsibility

a. Confirming or Revoking the Detention Order 

i. Time Period for Rendering Decision

As referenced in subsection 5-5-3 "Appeal of a Detention 

Order - Background," the presiding officer must by order, 

confirm or revoke the detention order within five (5) working 

days of the receipt of the appeal by the division director, if 

there is no hearing requested or if the appellant requests a 

hearing within five (5) working days. However, if the appellant 

requests a hearing later than the referenced five (5) working 

day time frame, but not later than twenty (20) calendar days 

after issuance of the detention order, then the presiding officer 

must, by order, confirm or revoke the detention order within 

five (5) working days after the close of the hearing. 21 CFR 

800.55(g)(5) and (6). The detention may not be extended past 

the otherwise applicable thirty (30)-day period (see "Appeal of 

a Detention Order - Background") without the consent of the 

appellant.

ii. Basis for Rendering Decision

If the Agency can show that it had a reason to believe that the 

devices were adulterated or misbranded at the time of the 

detention under one or more of the charges in the detention 

order, the presiding officer will affirm the detention order. If not, 

the presiding officer will revoke the detention order.
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iii. Issuance of the Order

The decision is issued in the form of an order. (See Exhibit

5-18 for model order.) The parties to the appeal should be 

orally notified of the order immediately. Copies of the order 

should then be mailed to them via certified mail return receipt 

requested.

FDA must order the decision rendered on the detention within 

the above time frames; however, the completion of the written 

decision and report of the hearing (discussed below) cannot 

delay the order. Normally, the order is consolidated with the 

written decision and report of the hearing. However, there are 

cases when the Agency needs additional time to complete the 

written decision and report of the hearing. In that case, it is 

separate from and will shortly follow the order.

b. Written Decision and Report of Hearing

The presiding officer must prepare a written decision to include the 

reasons and basis for his decision. 21 CFR § 16.95(b)(2). The written 

decision must include the report of the hearing required by Section 

201(x)(5) of the Act and 21 CFR 16.60(e). All written material submitted 

during the hearing must be attached to the written decision and report of 

the hearing (Section 201(x)(5) of the Act and 21 CFR 16.60(e)). Any 

transcripts of the hearing must be included.

Whenever time permits, the participants will be given the opportunity to 

review and comment on the written decision and report of the hearing. 

However, the presiding officer should set a time limit for the participants 

to comment. (As previously noted, whenever possible, the written 

decision and report of the hearing should be issued with the order as a 

single document).

c. Administrative Record of the Hearing

The presiding officer must prepare the Administrative Record of the 

Hearing, which consists of the following items:

i. The detention order and the appeal.

ii. All written information and views submitted to the presiding 

officer in conjunction with the hearing.

iii. Any transcript of the hearing.

iv. The presiding officer's written decision, report of the hearing, 

order, and any comments on the written decision or report of the 
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hearing permitted under Section 201(y) of the Act and 21 CFR 

16.60(e).

v. All letters and memoranda of meetings and communications 

between participants and the presiding officer referred to in 21 

CFR 16.44(c).

File the original Administrative Record of the Hearing with the firm’s official 

file at the division office after completion of the report. A copy should be 

forwarded to the center involved for its information. A copy should be 

maintained in the office of the Division that held the hearing.

2. FOI Requests

21 CFR Part 20 applies to all requests for documents involved in administrative 

detentions.

5-7 LICENSE REVOCATION OR SUSPENSION

5-7-1 Purpose

This section contains procedures for revoking and suspending biologic licenses issued 

under the Public Health Service Act (PHS Act) [42 U.S.C. 264]. These procedures are 

applicable to actions recommended by the division or by CBER.

"Revocation" is the cancellation of a license and the withdrawal of the authorization to 

introduce or deliver for introduction into interstate commerce, biological products, at 

either the request of the manufacturer or when grounds exist for the Agency to initiate 

such an action.

"Suspension" is a summary action taken by the Agency and may be an initial or 

intermediate step in the revocation process. Suspension provides for the immediate 

withdrawal of the authorization to introduce or deliver for introduction, biological 

products into interstate commerce when the Commissioner has reasonable grounds to 

believe that any of the grounds for revocation exist and that by reason thereof there is a 

danger to health.

5-7-2 General

Licenses issued for the manufacture of specific biologic products under the provisions of 

Section 351(a) of the PHS Act, may be: 1) revoked upon request of the licensee or by 

initiative of the Commissioner when sufficient grounds exist; or 2) suspended if one or 

more of the grounds for revocation exists and presents a danger to health (see 21 CFR 

601.5 and 601.6).
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CBER’s Office of Compliance and Biologics Quality (OCBQ), Division of Case 

Management (DCM) reviews recommendations for license revocation and suspension 

proposed by the division offices or the appropriate unit within CBER. If DCM concurs 

with the recommendation, it is forwarded to OCC for review. If OCC concurs, the 

recommendation and action letter are sent to the Director, CBER for concurrence and 

signature. Pursuant to SMG 1410.203, the Commissioner has delegated the authority to 

issue notices of revocation and suspension to the Director and Deputy Director, CBER.

OCBQ ensures that recommendations for license revocation or suspension are 

supported with evidence of violations of the applicable statutes and regulations. License 

suspensions and revocations are significant enforcement actions with possible farreaching consequences. As such, it is important to consider the impact that the action 

may have on product supply as part of the Agency's review of a proposed license 

suspension or revocation action.

When the license relates to multiple locations, revocation may be limited to one or more 

of the locations, if inspectional findings support that approach.

In the absence of willful noncompliance or a history of violations of a significant nature, 

the division or CBER inspection review unit considers issuing a Warning Letter or 

conducting a meeting with the firm, rather than recommending revocation as a firstchoice remedy.

Part V of the Compliance Program Guides for inspections of CBER-regulated products 

contains information on deviations that may warrant regulatory or administrative action. 

These inspection programs are located on CBER’s Compliance Programs page.

5-7-3 General Considerations for Revocation

The Agency may consider revocation of a biologic license when any of the conditions 

specified in 21 CFR 601.5 exist. In establishing that the grounds for revocation in 21 

CFR 601.5 are met, the recommending unit considers the two courses of action 

provided in the regulations: 1) notice of intent to revoke with the possibility of 

demonstrating or achieving compliance, or 2) in cases involving willfulness, notice of 

FDA's intention to move directly to revocation without providing an opportunity to 

demonstrate or achieve compliance.

1. Notice of Intent to Revoke

Inspectional findings must demonstrate a current history of repeated or 

continuous significant deviations that represent a breakdown of process controls, 

rather than isolated incidents. Ordinarily, a demonstration of prior warning to the 

firm is via Warning Letter and/or a meeting or other contact with the firm before 

consideration of license revocation. If a past Warning Letter issued and one or 

more non-violative inspection(s) follows it, a recommendation for license 

revocation based on current significant deficiencies must document whether the 
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deficiencies are of a continuing nature and how the current inspection relates to 

any previous inspection which resulted in the Warning Letter or other 

communication with the firm that provided the firm notice of such deficiencies. 

Issuance of a Warning letter in the past may not preclude issuance of an 

additional Warning Letter, especially if the nature and cause of the violation have 

changed. For example, a firm issued a Warning Letter three years ago for viral 

marker testing violations may warrant issuance of another Warning Letter or 

other action, rather than proceeding to license revocation, if the current 

inspection shows violations in different areas of the operation or manufacturing 

practices, e.g., computer validation.

In addition, FDA may proceed to revocation upon suspension of a license, as 

provided by 21 CFR 601.6(b).

Upon issuance of a "Notice of Intent to Revoke" letter (except in cases involving 

willfulness), we provide the licensee an opportunity to demonstrate or achieve 

compliance before instituting proceedings for revocation of the license.

2. Direct Revocation

FDA may proceed directly to revocation in cases involving willful conduct.

Willful conduct is established by showing that an individual: 1) knowingly 

committed a prohibited act, such as records falsification or concealment; or 2) 

acted with careless disregard of the regulatory requirements, as exemplified by 

repeatedly failing to correct violations. In cases involving willfulness, FDA 

ordinarily does not provide the licensee with the opportunity to demonstrate or 

achieve compliance, in accordance with 21 CFR 601.5(b). In all cases, FDA 

notifies the licensee of the opportunity to request a hearing pursuant to 21 CFR 

12.21(b).

5-7-4 Issues Not Supporting License Revocation

CBER ordinarily will not support license revocation when the following issues are the 

basis for the recommendation to revoke:

1. Biological Product Deviation Reports

Biological product deviation reports, in and of themselves, ordinarily may not 

form the basis for a license revocation unless the firm failed to recognize the 

error, failed to investigate and properly document the investigation, failed to 

implement corrective action to prevent its recurrence, or failed to notify FDA if so 

required under 21 CFR 600.14. In addition, in order to meet the grounds for 

license revocation, the deviation must be of such a nature or extent as to 

represent a firm's failure to establish or maintain control over one or more of the 

systems employed for the manufacture of biological products.
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2. Isolated Incidents

Isolated occurrences do not ordinarily establish grounds for license revocation, 

unless there is documentation to demonstrate that the occurrences represent a 

pattern of violative activity.

3. Past Violations

Violations that occurred prior to the current FDA inspection, and for which 

implementation of appropriate corrective action prevents reoccurrence, ordinarily 

do not form the basis for license revocation. However, FDA must document 

previous violations even with correction, or no repeats, because they may 

demonstrate a pattern or history of non-compliance. If violations persist, such a 

pattern is pertinent to a future decision to proceed to revocation.

5-7-5 Revocation Procedures

If the inspection review unit is considering revocation as an enforcement option, contact 

CBER, DCM, during the inspection or soon after issuance of the FDA 483. Discussions 

with CBER prior to submission of a recommendation will facilitate the processing of the 

recommendation.

If the inspection review unit believes license revocation is appropriate, that office 

submits a recommendation to DCM for revocation with supporting documentation. 

Include the division director’s concurrence on recommendations for revocation. In 

addition to forwarding documentation of the violations, the recommending unit submits a 

detailed summary of the firm's inspectional and compliance history over the past five 

years. The recommending unit also assesses the impact of license revocation on the 

supply of the biological products involved. The initial CBER contact is DCM, HFM-610, 

240-402-9155.

CBER assigns a consumer safety officer from HFM-610 to each revocation 

recommendation. If using express delivery, send to:

Food and Drug Administration

Center for Biologics Evaluation & Research

Attn: Division of Case Management (HFM-610)

WO Building 75 Room 5004

10903 New Hampshire Ave.

Silver Spring, MD 20993

CBER personnel review the information received and determine whether the 

inspectional findings support revocation of the firm's license.
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If CBER does not concur with the revocation recommendation, it communicates its 

decision to the recommending unit. CBER sends a memorandum confirming the 

reasons for the disapproval and provides other enforcement options, if appropriate.

If CBER concurs with the division’s recommendation, it prepares an Action 

Memorandum with supporting documentation to the Director, CBER, and a letter 

notifying the licensee of the Agency's intention to initiate proceedings to revoke the 

license. This package is forwarded to OCC for review (see RPM Chapter 4, Exhibit 4-1). 

If OCC concurs, the recommendation and action letter are sent to the Director, CBER 

for concurrence and signature. Recommendations that CBER has initiated are also 

routed to the Director of CBER for clearance. Prior to doing so, however, the CBER 

initiating office contacts the appropriate division office to advise the division of the action 

proposed by CBER.

After the Director signs the letter, the Director, DCM verbally advises the most 

responsible person at the firm of the Agency's intention to revoke the license. DCM then 

transmits a copy of the letter to the firm electronically (by e-mail or fax) and sends the 

original with proof of delivery.

CBER’s OCBQ advises the division office and/or recommending unit within CBER of the 

action concurrently. In addition, OCBQ transmits copies of the Action Memorandum and 

the revocation letter to the recommending unit via e-mail.

Both CBER and the recommending unit review the establishment's response to the 

letter of revocation expeditiously. The recommending unit provides CBER with its 

conclusions and comments regarding the adequacy of the firm's response.

The Agency usually gives an establishment the opportunity to demonstrate or achieve 

compliance. If the establishment has not waived its opportunity for a hearing by 

voluntarily requesting revocation, CBER's OCBQ and the firm continue to correspond 

until all corrective actions appear satisfactory. CBER will distribute copies of all 

correspondence between CBER and the firm to the recommending unit for review. 

When the recommending unit and CBER's OCBQ agree that all corrective actions 

appear satisfactory, CBER will ask the division office to conduct a follow up inspection 

expeditiously.

The division will advise CBER of the approximate date of reinspection and notify CBER 

by telephone or electronically of its findings and recommendation. Afterwards, the 

division sends a written recommendation either to move toward revocation or to 

discontinue proceedings for license revocation.

In some instances, the firm may have made significant progress in demonstrating or 

achieving compliance, but after review of the FDA 483 and the firm's response(s), the 

division and/or CBER may view a limited follow-up inspection as necessary prior to 

making a final determination on the matter of revocation.
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Following reinspection, if CBER and the division determine that the firm demonstrated 

or achieved compliance, CBER will notify the firm of this determination.

In cases involving willfulness, ordinarily the establishment has ten (10) days from the 

date of the revocation letter to waive the opportunity for hearing by requesting voluntary 

revocation in writing. If the establishment does not waive the opportunity for a hearing 

by surrendering the license within the ten (10)-day time frame, DCM forwards a request 

to CBER’s Regulations and Policy Staff, to prepare the Federal Register Notice of 

Opportunity for Hearing.

FDA publishes the Notice of Opportunity for Hearing on a proposal to revoke a license 

in the Federal Register together with an explanation of the grounds for the proposed 

action. A person subject to the notice has thirty (30) days after its issuance to request a 

hearing. There is no extension of the thirty (30)-day period. A request for hearing must 

set forth specific facts showing that there is a genuine and substantial issue of fact that 

justifies a hearing, and may not rely upon mere allegations or denials.

5-7-6 General Considerations For Suspension

Pursuant to 21 CFR 601.6, the Commissioner may suspend a license if the 

Commissioner has reasonable grounds to believe that any of the grounds for revocation 

exist and that by reason thereof there is a danger to health. Investigators obtain

documentary evidence to support revocation and danger to health, and CBER conducts 

an evaluation of the danger to health.

Once CBER determines that a danger to health exists, the recommending unit 

immediately contacts the appropriate state health authorities. In addition, the division

considers legal actions such as injunction or seizure, particularly if a given state health 

department lacks regulatory authority over intrastate operations or if the license 

suspension does not result in immediate corrective action. The recommending unit 

provides CBER with any information obtained regarding the state health department 

authority and the likelihood it may take regulatory action based on FDA's findings.

If a blood establishment is involved, the recommending unit determines the approximate 

number of annual collections and the percentage of blood products distributed in 

interstate commerce. The recommending unit, together with CBER, examines supply 

issues and considers contacting the large national blood organizations to ensure that a 

license suspension will not adversely affect the public health.

As in the case of revocation, when there are multiple locations encompassed by one 

license, suspension may be limited to one or more of the locations, if inspectional 

findings warrant that approach.
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5-7-7 Suspension Procedures

If the inspecting unit believes a danger to health exists, it should contact CBER’s DCM, 

HFM-610, 240-402-9155 immediately, during the inspection, and provide specific, 

substantive information relating to the grounds for suspension. It must not wait until the 

conclusion of the inspection to make contact. At that time, DCM assigns a consumer 

safety officer from HFM-610 to the suspension recommendation who will work with the 

investigators in case development.

The inspecting unit should transmit a copy of the FDA 483 (draft or final copy) as quickly 

as possible to DCM by facsimile, e-mail, or express delivery, along with any additional 

requested preliminary information and/or documentation. To avoid delay, do not send 

supporting documentation through the regular mail system if other means of 

transmission are available. If using overnight express delivery, send to:

Food and Drug Administration

Center for Biologics Evaluation & Research

Attn: Division of Case Management (HFM-610)

Building 75, Room 5004

19093 New Hampshire Avenue

Silver Spring, MD 20993

DCM will consult, as necessary, with the appropriate scientific/medical staff to 

determine if a danger to health exists. If a danger to health exists, the inspecting office 

will be advised and should submit a recommendation in a brief memorandum that 

includes the basis of the recommendation. Transmit the recommendation by e-mail. 

Recommendations for suspension are given a high priority and supervisors are to act 

promptly. Recommendations for suspension should have the concurrence of the 

division director. The division will make every effort to expedite the submission of a 

recommendation to CBER to suspend operations under license at an establishment 

whose practices present an imminent danger to health.

Frequently DCM may concur with a suspension recommendation after receiving the 

FDA 483 but before receiving the EIR. In cases involving complex issues, DCM may 

need to review the completed EIR before reaching a decision. In either event, write the 

EIR promptly and forward by express mail service to DCM.

Depending upon the products involved, CBER may ask the recommending unit to obtain 

a complete inventory of the products on the firm's premises.

If DCM concurs with the suspension recommendation, it will prepare an Action 

Memorandum and a letter of suspension within three (3) working days of receipt of the 

recommendation. Documents will be sent to OCC for review as soon as available. See 

RPM Chapter 4, Exhibit 4-1. Upon OCC concurrence, the Director, CBER, who notes 

the date and time of signature, signs the Action Memorandum and letter of suspension. 

The Director, OCBQ or DCM will immediately telephone the firm and advise it of the 
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suspension of its biologics license. DCM will then send the letter to the firm 

electronically and by certified mail.

CBER may concurrently advise the recommending unit of FDA's action. In some 

situations, CBER may arrange to transmit a copy of the suspension letter to the division

for hand delivery to the firm.

If CBER does not concur with a suspension recommendation, it communicates its 

decision to the recommending unit. DCM will prepare a memorandum explaining the 

reasons for the disapproval. If CBER disagrees with the suspension recommendation 

based on the absence of a danger to health, and any of the conditions specified in 21 

CFR 601.5(b) exist, DCM considers whether it is appropriate to revoke the license or 

send a Warning Letter and will discuss these options with the recommending unit.

DCM and the recommending unit concurrently review the reply to a letter of suspension 

and continue to correspond with the firm until both agree that all corrective actions 

appear satisfactory. At this point, DCM notifies the firm, ordinarily by telephone (later 

confirmed by letter), that limited operations may resume for the purpose of a 

reinspection to determine that the corrective actions implemented are effective. CBER 

requests that the division office conduct a follow up inspection expeditiously, generally 

within thirty (30) days of resumption of limited operations.

The division office advises CBER of the approximate date of reinspection. As soon as 

possible upon its conclusion, the division notifies CBER by telephone of its findings and 

recommendation (CBER contact is DCM, HFM-610, 240-402-9155). The division

follows-up by sending a written recommendation on the last day of the inspection or 

shortly thereafter. If issuing a FDA 483, the division forwards a copy of the firm's 

response, if any, to CBER. In addition, the division sends a written copy of the 

establishment inspection report to CBER as quickly as possible to support continued 

suspension, revocation or reinstatement.

In some instances, the firm may have made significant progress in achieving 

compliance, but after review of the FDA 483 and the firm's response(s), the division

and/or CBER may view a limited follow-up inspection as necessary prior to making a 

final determination as to whether to recommend reinstatement of the license.

If the follow-up inspection indicates inadequate corrective actions and continued 

deviations, the division obtains additional documentation and notifies CBER as soon as 

possible. CBER decides whether to allow the firm to continue in limited operations or to 

cease all operations. In addition, CBER considers the possibility of proceeding toward 

license revocation.

If the firm is achieving compliance, CBER prepares an Action Memorandum and letter 

of reinstatement for the signature of the Director, CBER. After the letter is signed, the 

Director OCBQ or DCM telephones the firm and advises it that the Agency has lifted the 
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suspension of the firm's activities and they may now ship products collected or 

manufactured since the date they resumed limited operations. Also, DCM advises the 

division by telephone and sends a copy of the reinstatement letter, which, if appropriate, 

may contain instructions to the firm for filing a request to use products in inventory at the 

time of suspension.

On a case-by-case basis, CBER evaluates written requests for release of products in 

inventory at the time of suspension. Communicate in writing all decisions regarding the 

disposition of products to the firm (copy to the division). CBER may request that the 

division monitor the disposition of the inventory.

Send copies of all correspondence, verbal and written communications, and EIRs 

relating to suspensions of operations under license, to the attention of:

Food and Drug Administration

Center for Biologics Evaluation & Research

Bldg 75, Room 5004

10903 New Hampshire Avenue

Silver Spring, MD 20903

ATTN: Division of Case Management, HFM-610

5-8 ORDERS OF RETENTION, RECALL, DESTRUCTION AND 

CESSATION OF MANUFACTURING RELATED TO HUMAN CELL, 

TISSUE AND CELLULAR AND TISSUE-BASED PRODUCTS 

(HCT/Ps)

5-8-1 Purpose

This section contains procedures for issuing an Order of Retention, Recall, Destruction 

and Cessation of Manufacturing (Order) related to human cell, tissue, and cellular and 

tissue-based products (HCT/Ps) pursuant to 21 CFR 1271.440 - promulgated under 

section 361 of the PHS Act.

5-8-2 Background

In February 1997, FDA proposed a new, comprehensive approach to the regulation of 

human cells, tissues, and cellular and tissue-based products (HCT/Ps). FDA proposed a 

tiered, risk based approach under which some HCT/Ps would be regulated only under 

Section 361 of the PHS Act and the newly proposed regulations in order to prevent the 

introduction, transmission, and spread of communicable diseases. Other HCT/Ps would 

also be regulated as drugs, devices, and/or biological products.

Since that time, the agency has published multiple regulations to fully implement this 

approach. In January 2001, we issued regulations to create a new, unified system for 
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registering HCT/P establishments and for listing their HCT/Ps (66 FR 5447). In May 

2004, FDA issued regulations requiring most cell and tissue donors to be tested and 

screened for risk factors for, and clinical evidence of, relevant communicable disease 

agents and diseases (69 FR 29786). In November 2004, FDA issued regulations 

requiring HCT/P establishments to follow current good tissue practice (CGTP), which 

governs the methods used in, and the facilities and controls used for, the manufacture 

of HCT/Ps; recordkeeping; and the establishment of a quality program. The CGTP 

regulations also contain certain labeling and reporting requirements, as well as 

inspection and enforcement provisions (69 FR 68612). These regulations apply to 

HCT/Ps recovered on or after May 25, 2005. HCT/Ps that were recovered before this 

effective date are subject to 21 CFR Part 1270, and subparts A and B of Part 1271, as 

appropriate.

HCT/Ps that meet all of the criteria set forth in 21 CFR 1271.10(a) are subject to 

regulation solely under 21 CFR Part 1271 and section 361 of the PHS Act, so no 

premarket approval is required. HCT/Ps that do not meet all of the criteria in 21 CFR 

1271.10(a) are regulated also as drugs, devices, and/or biological products.

Part 1271 contains six subparts:

Subpart A of Part 1271 – scope, purpose, and definitions

Subpart B of Part 1271 - registration

Subpart C of Part 1271 - screening and testing of donors to determine eligibility

Subpart D of Part 1271 - provisions on CGTP

Subpart E of Part 1271 - certain labeling and reporting requirements

Subpart F of Part 1271 - inspection and enforcement provisions. 

The subparts apply as follows:

• Subparts A through D apply to all HCT/Ps, i.e., to HCT/Ps regulated solely 

under section 361 of the PHS Act and Part 1271, as well as to those regulated 

as drugs, devices, and/or biological products. 

• Subparts E and F, which pertain to labeling, reporting, inspection, and 

enforcement, apply only to those HCT/Ps regulated solely under section 361 of 

the PHS Act and Part 1271. However, with the exception of two provisions (Sec. 

Sec. 1271.150(c) and 1271.155), subparts D and E are not being implemented 

for reproductive HCT/Ps.

21 CFR 1271.440 authorizes FDA to issue Orders of Retention, Recall, Destruction, 

and Cessation of Manufacturing in certain circumstances. Such an order is intended 

for use in situations when needed to prevent the introduction, transmission, or spread 

of communicable diseases, and applies only to those HCT/Ps regulated solely under 

section 361 of the PHS Act and Part 1271.
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5-8-3 General Considerations

The agency may consider an Order of Retention, Recall, Destruction, or Cessation of 

Manufacturing when any of the conditions specified in 21 CFR 1271.440(a) exist. 

Under this provision, an Order may be justified when the agency finds that there are 

reasonable grounds to believe that an HCT/P is a violative HCT/P because:

1. The HCT/P was manufactured in violation of the regulations in Part 1271 and, 

therefore, the conditions of manufacture of the HCT/P do not provide adequate 

protections against the risk of communicable disease transmission; or

2. The HCT/P is infected or contaminated so as to be a source of dangerous 

infection to humans; or

3. An establishment is in violation of the regulations in Part 1271 and, therefore 

does not provide adequate protections against the risks of communicable 

disease transmission.

Based upon one or more of the above findings, the agency may order the retention, 

recall, and/or destruction of the violative HCT/P; take possession of and/or destroy the 

violative HCT/Ps; or order the establishment to cease manufacture until compliance with 

Part 1271 has been achieved.

NOTE: FDA will not issue an order for the destruction of reproductive HCT/Ps, nor will 

FDA carry out such destruction itself. 21 CFR 1271.440(f).

5-8-4 Procedures for Orders of Retention, Recall, or Destruction of HCT/Ps

An Order of Retention, Recall, or Destruction of HCT/Ps may be appropriate in 

situations where there are significant concerns regarding the source or violative nature 

of the HCT/P, the adequacy of the screening and/or testing, or a failure of the 

establishment to fulfill stated commitments to gain control over violative HCT/Ps.

As soon as practicable after the possibility of issuing an Order of Retention, Recall, or 

Destruction is first identified, the division should contact the Chief, Blood and Tissue 

Compliance Branch (BTCB)/DCM, in CBER’s OCBQ. It is important to make this initial 

contact during the inspection if possible; do not wait until the conclusion of the 

inspection to contact CBER. Discussions with CBER prior to submission of a 

recommendation will facilitate the processing of the recommendation.

The division should upload a copy of the FDA 483 (draft or final) into CMS along with 

any additional, preliminary information and/or documentation as quickly as possible and 

should notify BTCB/DCM, for example by e-mail. BTCB/DCM, will notify CBER’s Office 

of Cellular, Tissue, and Gene Therapies (OCTGT) and OCC of the potential for an 

Order as appropriate.
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If the division believes an Order of Retention, Recall, or Destruction is appropriate, 

complete documentation of the violative conditions should be collected, including an 

inventory of products on the premises as well as those products distributed (including 

names and addresses of consignees and HCT/Ps shipped to consignees) as of the last 

day of the inspection.

The division prepares and submits a written recommendation for an Order of Retention, 

Recall, or Destruction to CBER. Include the division director’s concurrence with 

recommendations for Orders. Transmit the Order recommendation, FDA 483, and all 

supporting documentation via MARCS-CMS or, where needed, by e-mail.

All divisions should identify Order recommendations as high priorities and make every 

effort to expedite submissions of the documents described above. BTCB/DCM reviews 

the information received, also as a high priority, and determines whether the 

inspectional findings support the issuance of an Order of Retention, Recall, or 

Destruction.

CBER may concur with issuance of an Order after reviewing the FDA 483 and 

supporting documentation, but before receiving the EIR, if the violations are serious and 

if there are not adequate protections against risks of communicable disease 

transmission. It is essential that the division completes the EIR expeditiously and 

forwards it, along with the exhibits and additional supporting documentation, by 

uploading it into MARCS-CMS. In cases involving complex issues, CBER may need to 

review the completed EIR before deciding whether to concur with the recommendation 

to issue an Order.

BTCB/DCM transmits the FDA 483 and other available supporting documentation as 

needed to the Division of Human Tissues (DHT), OCTGT. If one or more of the 

conditions in 21 CFR 1271.440(a) (as described above in subsection 5-7-2) are present, 

DHT will confirm this in writing, signed by the Director, DHT or designee.

If CBER concurs with the Order recommendation, and OCTGT has confirmed that one 

or more of the conditions in 21 CFR 1271.440(a) are present, BTCB/DCM drafts the 

Order of Retention, Recall, or Destruction.

The draft Order, FDA 483, and supporting documentation are uploaded into 

MARCS-CMS for OCC review. If OCC concurs with the issuance of the Order, 

BTCB/DCM prepares the Order for signature by the CBER Center Director and delivers 

it to the Office of the Center Director for signature.

On the date that the Order is signed, the Director, OCBQ attempts to contact the HCT/P 

establishment by phone to notify the establishment that the Order is in effect. A copy of 

the order will be sent to the establishment by fax if possible, as soon as possible, after 

this call has taken place.
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Also on the date the Order is signed, BTCB/DCM forwards the Order via overnight 

delivery to the division office for delivery to the HCT/P establishment. It is preferable to 

have the original, signed Order hand-delivered to the HCT/P establishment by an FDA 

investigator. If this is not practicable, the original signed order can be sent to the HCT/P 

establishment via overnight delivery.

If CBER does not concur with the Order recommendation, BTCB/DCM will notify the 

division regarding this decision by telephone or electronic mail, and forward a 

memorandum to the responsible division official explaining the reasons for nonconcurrence and describing other potential regulatory actions, if appropriate.

If OCC does not concur with the Order recommendation, OCC will provide a written 

statement of its rationale to CBER, with a copy to the division office.

5-8-5 Follow-Up to Orders of Retention, Recall, or Destruction

The Order of Retention, Recall, or Destruction will ordinarily provide that the HCT/P be 

recalled and/or destroyed within five (5) working days from the date of receipt of the 

Order. The division should promptly verify that the recall and/or destruction is carried 

out expeditiously, and the HCT/P establishment’s action should be monitored or 

witnessed, as appropriate, by an FDA investigator. The division should manage recalls 

as provided for in Chapter 7. The Order will require the HCT/P establishment to notify its 

consignees to return or retain affected HCT/Ps in their inventories.

As an alternative to proceeding with recall and/or destruction, other arrangements for 

ensuring the proper disposition of the HCT/P may be agreed upon by the person 

receiving the written Order and FDA. Such arrangements may include, among other 

things, providing FDA with records or other written information that adequately ensures 

that the HCT/P has been recovered, processed, stored and distributed in compliance 

with the regulations and that, except as provided under 21 CFR 1271.60, 1271.65, and 

1271.90, the donor of the cells or tissue for the HCT/P has been determined to be 

eligible. If the violative HCT/Ps can be reconditioned to become suitable for 

implantation, transplantation, infusion, or transfer into a human recipient as a result of 

these corrective actions, the establishment may be authorized to release the HCT/P for 

distribution.

If alternative arrangements are proposed by the HCT/P establishment, the division and 

CBER should review the proposal concurrently. The HCT/P establishment must retain 

the violative HCT/Ps in quarantine status until FDA agrees that the appropriate 

corrective actions have been implemented and adequate documentation has been 

provided to FDA to address the issues identified in the Order of Retention, Recall, or 

Destruction.

If FDA orders the destruction of HCT/Ps, it is the firm’s responsibility to destroy all 

violative HCT/Ps and provide to FDA records documenting destruction. The division

monitors the destruction of violative HCT/Ps and obtains destruction records.
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The regulations provide the agency with the authority to take possession of and/or 

destroy the violative HCT/Ps. The division must notify BTCB/DCM if it believes that 

taking possession of HCT/Ps may be appropriate. If CBER agrees that taking 

possession of HCT/Ps is appropriate in a particular situation, CBER will provide 

guidance on procedures for handling and destroying the HCT/Ps safely.

The division will schedule a follow-up inspection as appropriate. If the division observes 

continued deviations, it should contact BTCB/DCM during the inspection. The division

and CBER will jointly consider what action to take.

5-8-6 Procedures for Orders of Cessation of Manufacturing

An Order of Cessation of Manufacturing may be appropriate in situations where there 

are significant concerns regarding one or more steps in the manufacture of HCT/Ps, or 

a failure of the establishment to fulfill stated commitments to gain control over or to bring 

the areas of manufacturing into compliance with the applicable regulations.

As soon as practicable after the possibility of issuing an Order of Cessation of 

Manufacturing is first identified, the division should contact the Chief, BTCB/ DCM, in 

CBER’s OCBQ. It is important to make this initial contact during the inspection if 

possible; do not wait until the conclusion of the inspection to contact CBER. Discussions 

with CBER prior to submission of a recommendation will facilitate the processing of the 

recommendation.

The division should transmit a copy of the FDA 483 (draft or final) as quickly as possible 

to BTCB/DCM by e-mail, along with any additional, preliminary information and/or 

documentation. BTCB/DCM will notify CBER’s OCTGT and OCC of the potential for an 

Order as appropriate.

If the division believes an Order of Cessation of Manufacturing is appropriate, complete 

documentation of the violative conditions should be collected, including an inventory of 

products on the premises as of the last day of the inspection.

An Order of Cessation of Manufacturing will be effective immediately if FDA determines 

there are reasonable grounds to believe there is a danger to health. BTCB/DCM will 

consult, as necessary, with the appropriate scientific/medical staff to determine whether 

there are reasonable grounds to believe that there is a danger to health. This evaluation 

will be documented by BTCB/DCM, working with appropriate scientific/medical staff. If a 

determination is made that a danger to health exists, the division will be advised 

immediately.

The division prepares and submits a written recommendation for issuance of an Order 

of Cessation of Manufacturing to CBER. Include the division director’s concurrence with 
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recommendations for Orders. Transmit the Order recommendation, FDA 483, and all 

supporting documentation via MARCS-CMS or, where needed, by electronic mail.

All divisions should identify Order recommendations as high priorities and make every 

effort to expedite submissions of the documents described above. BTCB/DCM reviews 

the information received, also as a high priority, and determines whether the 

inspectional findings support the issuance of an Order of Cessation of Manufacturing.

CBER may concur with issuance of an Order after reviewing the FDA 483 and 

supporting documentation, but before receiving the EIR if the violations are serious and 

if there are not adequate protections against the risks of communicable disease 

transmission. It is essential that the division completes the EIR expeditiously and 

forwards it to BTCB/DCM, along with the exhibits and additional supporting 

documentation, by uploading it into MARCS-CMS. In cases involving complex issues, 

CBER may need to review the completed EIR before deciding whether to concur with 

the recommendation to issue an Order.

BTCB/DCM transmits the FDA 483 and other available supporting documentation as 

needed to the Division of Human Tissues (DHT), OCTGT. If one or more of the 

conditions in 21 CFR 1271.440(a) (as described above in subsection 5-7-2) are present, 

DHT will confirm this in writing, signed by the Director, DHT (or designee). If there are 

reasonable grounds to believe there is a danger to health, this must also be 

documented and signed by the Director, DHT (or designee).

If CBER concurs with the Order recommendation, and OCTGT has confirmed that one 

or more of the conditions in 21 CFR 1271.440(a) are present, BTCB/DCM drafts the 

Order of Cessation of Manufacturing.

The draft Order, FDA 483, and supporting documentation are uploaded into 

MARCS-CMS for OCC review. If OCC concurs with the issuance of the Order, 

BTCB/DCM prepares the Order for signature by the CBER Center Director and delivers 

it to the Office of the Center Director for signature.

On the date that the Order is signed, the Director, OCBQ attempts to contact the HCT/P 

establishment by phone to notify the establishment that the Order is in effect. A copy of 

the Order will be sent to the establishment expeditiously, by fax or e-mail if possible, as

soon as possible after this call has taken place.

Also on the date the Order is signed, BTCB/DCM forwards the Order via overnight 

delivery to the division office for delivery to the HCT/P establishment. It is preferable to 

have the original, signed Order hand-delivered to the HCT/P establishment by an FDA 

investigator. If this is not practicable, the original signed order can be sent to the HCT/P 

establishment via overnight delivery.
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If CBER does not concur with the Order recommendation, BTCB/DCM will notify the 

division regarding this decision by telephone or electronic mail, and forward a 

memorandum to the responsible division official explaining the reasons for nonconcurrence and describing other potential regulatory actions, if appropriate.

If OCC does not concur with the Order recommendation, OCC will provide a written 

statement of its rationale to CBER, with a copy to the division office.

5-8-7 Follow Up to Orders of Cessation of Manufacturing

When FDA determines there are reasonable grounds to believe there is a danger to 

health, an Order of Cessation of Manufacturing is effective immediately. In other 

situations, the Order of Cessation of Manufacturing is effective after one of the following

events, whichever is later: 1) passage of five (5) working days from the establishment’s 

receipt of the Order; or, 2) if the establishment requests a Part 16 hearing, a decision in 

the proceedings. The Order will specify the regulations with which the HCT/P 

establishment must achieve compliance and will ordinarily specify the particular 

operations covered by the Order. The establishment is permitted to implement 

corrective actions in order to resume operations. However, the firm may not resume any 

operations subject to the Order without written authorization from FDA.

The division and CBER should concurrently review all correspondence received 

subsequent to issuance of an Order of Cessation concurrently. All meetings between 

the FDA and the Order recipient should include the appropriate division and CBER 

personnel.

5-8-8 Part 16 Hearing

The recipient of an Order may request a hearing by submitting a written request in 

accordance with 21 CFR Part 16 as described in the Order and in 21 CFR 1271.440(e). 

The recipient must make the request within five (5) working days of receipt of a written 

Order of Retention, Recall, Destruction, and/or Cessation of Manufacturing, or within 

five (5) working days of the agency’s possession of an HCT/P. The HCT/P 

establishment may request additional time (beyond five (5) working days) to consider 

whether to request a hearing. Reasonable requests for additional time will usually be 

granted. \OCC, the ORA Ombuds, and FDA Office of the Ombudsman, and the division

office should be notified promptly upon receipt of a Part 16 hearing request, and for a 

request for additional time to request a hearing.

For an Order requiring destruction of HCT/Ps, a request for a Part 16 hearing places the 

portion of the Order requiring destruction of the violative tissue in abeyance, pending 

the outcome of the hearing. The portion of the Order requiring recall and retention of 

violative HCT/Ps, however, is not placed in abeyance or affected by the hearing 

request.
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As described above, if an Order of Cessation of Manufacturing is not immediately in 

effect, it is effective after one of the following events, whichever is later: 1) passage of 

five (5) working days from the establishment’s receipt of the Order; or, 2) if the 

establishment requests a Part 16 hearing, a decision in the proceeding. If a Part 16 

hearing is requested but denied, or if the Presiding Officer concludes after a Part 16 

hearing that the Order was properly issued, the procedures in section 5-7-6 will be 

followed to notify the HCT/P establishment of the requirement to cease manufacturing.

5-9 CIVIL MONEY PENALTIES AND NO-TOBACCO-SALE ORDERS

5-9-1 Civil Money Penalty Authorities

The Civil Money Penalties (CMPs) included in this section are monetary penalties that 

are assessed by FDA for violations of the FFDCA (the Act) or the PHS Act. Information 

on electronic products civil penalties under section 539(b) of the Act can be found in 

RPM Chapter 6, section 6-6.

CMPs are authorized under the following sections of the Act and the Public Health 

Service Act. See 21 CFR 17.2 for the current maximum CMP amounts allowed.

1. Food

a. Section 303(f)(2)(A) of the Act, 21 U.S.C. 333(f)(2)(A) – Authorizes CMPs 

against any person who introduces, or delivers for introduction, into 

interstate commerce an article of food that bears or contains a pesticide 

chemical residue that is unsafe within the meaning of section 408(a).

Section 303(f)(2)(B) of the Act, 21 U.S.C. 333(f)(2)(B), states that a CMP 

cannot be assessed against any person who grew the article of food. That 

section also prohibits use of the seizure, injunction, or criminal authorities 

if a CMP is assessed.

2. Drugs

a. Section 303(b)(2) of the Act, 21 U.S.C. 333(b)(2) – Authorizes CMPs 

against a manufacturer or distributor:

i. if one of their representatives, during the course of their employment or 

association with the manufacturer or distributor, is convicted of selling, 

purchasing, or trading or offering to sell, purchase, or trade a 

prescription drug sample in violation of section 503(c)(1) and 301(t); or 

is convicted of violating any State law that prohibits the sale, purchase, 

or trade of a prescription drug sample subject to section 503(b), or the 

offer to sell, purchase, or trade such a prescription drug sample.
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b. Section 303(b)(3) of the Act, 21 U.S.C. 333(b)(3) – Authorizes CMPs 

against a manufacturer or distributor:

i. if they fail to report to the Secretary any convictions of their 

representatives for violations of section 503(c)(1) or a State law 

because of the sale, purchase, or trade of a prescription drug sample, 

or the offer to sell, purchase, or trade a prescription drug sample.

c. Section 303(f)(3)(A) of the Act, 21 U.S.C. 333(f)(3)(A) – Authorizes CMPs 

against any person who violates section 301(jj), 21 U.S.C. 331(jj), by:

i. failing to submit the certification required by section 402(j)(5)(B) of the 

Public Health Service Act, 42 U.S.C. 282(j)(5)(B), when submitting 

certain human drug applications and submissions to FDA, or knowingly 

submitting a false certification;

ii. failing to submit clinical trial information required by section 402(j) of the

Public Health Service Act, 42 U.S.C. 282(j); or

iii. submitting clinical trial information under section 402(j), 42 U.S.C. 

282(j), that is false or misleading in any particular under section 

402(j)(5)(D), 42 U.S.C. 282(j)(5)(D).

d. Section 303(f)(3)(B) of the Act, 21 U.S.C. 333(f)(3)(B) – Authorizes CMPs 

(in addition to those under section 303(f)(3)(A) above) if a violation of 

section 301(jj), 21 U.S.C. 331(jj), is not corrected within the thirty (30)-day 

period following notification under section 402(j)(5)(C)(ii), 42 U.S.C. 

282(j)(5)(C)(ii), for each day of the violation after such period until the 

violation is corrected.

e. Section 303(f)(4)(A) of the Act, 21 U.S.C. 333(f)(4)(A) – Authorizes CMPs 

against any responsible person (defined in section 505-1, 21 U.S.C. 355-

1) that violates a requirement of:

i. Section 505(o), 21 U.S.C. 355(o) – Postmarket studies and clinical 

trials; labeling;

ii. Section 505(p), 21 U.S.C. 355(p) – Risk evaluation and mitigation 

strategy; or

iii. Section 505-1, 21 U.S.C. 355-1 – Risk evaluation and mitigation 

strategies.

f. Section 303(g)(1) of the Act, 21 U.S.C. 333(g)(1) – Authorizes CMPs 

against a person who is a holder of an approved new drug application for 

a prescription drug, or the holder of an approved biologics license 

application, if such person disseminates or causes another party to 
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disseminate a direct-to-consumer advertisement that is false or 

misleading.

g. Section 307(a) of the Act, 21 U.S.C. 335b (a) – Authorizes CMPs against 

any person that:

i. Knowingly made or caused to be made, to any officer, employee, or 

agent of the Department of Health and Human Services (“DHHS 

personnel”), a false statement or misrepresentation of a material fact in 

connection with an abbreviated new drug application (ANDA);

ii. bribed or attempted to bribe or paid or attempted to pay an illegal 

gratuity to “DHHS personnel” in connection with an ANDA;

iii. destroyed, altered, removed, or secreted, or procured the destruction, 

alteration, removal, or secretion of any material document or other

material evidence which was the property of or in the possession of

DHHS for the purpose of interfering with DHHS’s discharge of its 

responsibilities in connection with an ANDA;

iv. knowingly failed to disclose to an officer or employee of DHHS, a 

material fact relating to any drug subject to an ANDA, which such 

person had an obligation to disclose;

v. knowingly obstructed a DHHS investigation into any drug subject to an

ANDA;

vi. has an approved or pending drug product application and has 

knowingly used in any capacity the services of a person who was 

debarred under section 306; or

vii. is debarred and, during the period of debarment, provided services in 

any capacity to a person that had an approved or pending drug product 

application.

3. Biologics

a. Section 303(f)(3)(A) of the Act, 21 U.S.C. 333(f)(3)(A) – Authorizes CMPs 

against any person who violates section 301 (jj), 21 U.S.C. 331 (jj), by:

i. failing to submit the certification required by section 402(j)(5)(B) of the 

Public Health Service Act, 42 U.S.C. 282(j)(5)(B), when submitting 

certain biological product applications and submissions to FDA, or 

knowingly submitting a false certification;

ii. failing to submit clinical trial information required by section 402(j) of 

the Public Health Service Act, 42 U.S.C. 282(j); or

iii. submitting clinical trial information under section 402(j), 42 U.S.C. 

282(j), that is false or misleading in any particular under section 

402(j)(5)(D), 42 U.S.C. 282(j)(5)(D).

b. Section 303(f)(3)(B) of the Act, 21 U.S.C. 333(f)(3)(B) – Authorizes CMPs (in 

addition to those under section 303(f)(3)(A) above) if a violation of section 
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301(jj), 21 U.S.C. 331(jj), is not corrected within the thirty (30)-day period 

following notification under section 402(j)(5)(C)(ii), 42 U.S.C. 282(j)(5)(C)(ii), 

for each day of the violation after such period until the violation is corrected.

c. Section 303(f)(4)(A) of the Act, 21 U.S.C. 333(f)(4)(A) – Authorizes CMPs

against any responsible person (defined in section 505-1, 21 U.S.C. 355-1) 

that violates a requirement of:

i. section 505(o), 21 U.S.C. 355(o) – Postmarket studies and clinical 

trials; labeling;

ii. section 505(p), 21 U.S.C. 355(p) – Risk evaluation and mitigation 

strategy; or

iii. section 505-1, 21 U.S.C. 355-1 – Risk evaluation and mitigation 

strategies.

d. Section 303(g)(1) of the Act, 21 U.S.C. 333(g)(1) – Authorizes CMPs 

against a person who is a holder of an approved new drug application for 

a prescription drug, or the holder of an approved biologics license 

application, if such person disseminates or causes another party to 

disseminate a direct-to-consumer advertisement that is false or 

misleading.

e. Section 351(d)(2) of the Public Health Service Act, 42 U.S.C. 262(d)(2) –

Authorizes CMPs for any violation of an order issued by the Secretary to 

immediately recall a batch, lot, or other quantity of a licensed biological 

product that presents an imminent or substantial hazard to the public 

health.

f. Section 2128(b)(1) of the PHS Act, 42 U.S.C. 300aa-28(b)(1) – Authorizes 

CMPs against any vaccine manufacturer who intentionally destroys, alters, 

falsifies, or conceals any record or report required by 42 U.S.C. 300aa28(a)(1) or (2).

The penalty applies to the person who intentionally destroyed, altered, 

falsified, or concealed such record or report; to the person who directed 

that such record or report be destroyed, altered, falsified, or concealed; 

and to the vaccine manufacturer for which such person is an agent, 

employee, or representative. Each act of destruction, alteration, 

falsification, or concealment is treated as a separate occurrence.

4. Devices

a. Section 303(f)(3)(A) of the Act, 21 U.S.C. 333(f)(3)(A) – Authorizes 

CMPs against any person who violates section 301(jj), 21 U.S.C. 331 (jj), 

by:

i. failing to submit the certification required by section 402(j)(5)(B) of 

the PHS Act, 42 U.S.C. 282(j)(5)(B), when submitting certain 

device applications and submissions to FDA, or knowingly 

submitting a false certification;
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ii. failing to submit clinical trial information required by section 402(j) 

of the PHS Act, 42 U.S.C. 282(j); or

iii. submitting clinical trial information under section 402(j), 42 U.S.C. 

282(j), that is false or misleading in any particular under section 

402(j)(5)(D), 42 U.S.C. 282(j)(5)(D).

b. Section 303(f)(3)(B) of the Act, 21 U.S.C. 333(f)(3)(B) – Authorizes 

CMPs (in addition to those under section 303(f)(3)(A) above) if a 

violation of section 301(jj), 21 U.S.C. 331(jj), is not corrected within the 

thirty (30)-day period following notification under section 402(j)(5)(C)(ii), 

42 U.S.C. 282(j)(5)(C)(ii), for each day of the violation after such period 

until the violation is corrected.

c. Section 303(f)1)(A) of the Act, 21 U.S.C. 333(f)(1)(A)2 – Authorizes 

CMPs against any person who violates a requirement which relates to 

devices. Except that, in accordance with Section 303(f)(1)(B), CMPs do 

not apply to:

i. any person who violates the requirements of section 519(a) (e.g., 

Medical Device Reporting), or section 520(f) (Quality System 

Regulation), unless the violations constitute a significant or 

knowing departure from the requirements, or a risk to public 

health;

ii. any person who commits minor violations of section 519(e) 

(Device Tracking), or section 519(g) (only with respect to 

correction reports), if the person demonstrates substantial 

compliance with such section; or

iii. violations of section 501(a)(2)(A) which involve one or more 

devices which are not defective.

Note that a person accredited under section 704(g)(2) who is 

substantially not in compliance with the standards of accreditation under 

that section, or who poses a threat to public health or fails to act in a 

manner that is consistent with the purposes of that section, is considered 

to have violated a requirement of the Act that relates to devices.

5. Mammography Facilities

a. Section 354(h)(3) of the PHS Act, 42 U.S.C. 263b(h)(3) – Authorizes 

CMPs for:

i. Failure to obtain a certificate as required by 42 U.S.C. 263b(b);

2 This section has been variously referred to as section 303(f) and 303(g) because of confusion at the time of 

legislative enactment in 1990. The explanatory notes to FDAAA of 2007 clarified that this section is now subsection 

(f).
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ii. Each failure by a facility to substantially comply with, or each day 

on which a facility fails to substantially comply with, the quality 

standards established under 42 U.S.C. 263b(f), codified at 21 

CFR Part 900, or the requirements of 42 U.S.C. 263b(d)(1)(B)(ii);

iii. Each failure to notify a patient of risk as required pursuant to 42 

U.S.C. 263b(h)(2); and

iv. Each violation, or for each aiding and abetting in a violation of, 

any provision of, or regulation promulgated under, this section by 

an owner, operator, or any employee of a facility required to have 

a certificate.

6. Tobacco Products

a. Section 303(f)(9) of the Act, 21 U.S.C. 333(f)(9)– Authorizes CMPs for 

violations of tobacco product requirements.

b. Section 303(f)(9)(A) of the Act, 21 U.S.C. 333(f)(9)(A)– Authorizes CMPs 

against any person who violates a requirement of the Act which relates to 

tobacco products. Such person shall be liable to United States for a civil 

penalty in an amount not to exceed $15,000 for each such violation, and 

not to exceed $1,000,000 for all such violations adjudicated in a single 

proceeding.

c. Section 303(f)(9)(B) of the Act, 21 U.S.C. 333(f)(9)(B) – Authorizes 

enhanced CMPs in an amount not to exceed $250,000 per violation, and 

not to exceed $1,000,000 for all such violations adjudicated in a single 

proceeding.

i. if a person intentionally violates a requirement of:

• Section 902(5) of the Act, 21 U.S.C. 387b(5), which deems a 

tobacco product to be adulterated if it is, or purports to be or 

is represented as, a tobacco product which is subject to a 

tobacco products standard established under section 907 

unless such tobacco product is in all respects in conformity 

with such standard.

• Section 902(6) of the Act, 21 U.S.C. 387b(6), which deems a 

tobacco product to be adulterated if (A) it is required by 

section 910(a) to have premarket review and does not have 

an order in effect under section 910(c)(1)(A)(i). or (B) it is in 

violation of an order under section 910(c)(1)(A).

• Section 904 of the Act, 21 U.S.C. 387d, which requires each 

tobacco product manufacturer or importer, or agents thereof, 

to submit health information to the Secretary, as set forth in 

that section.

• Section 908(c) of the Act, 21 U.S.C. 387h(c), which requires 

the appropriate person (including the manufacturers, 
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importers, distributors, or retailers of the tobacco product) to 

immediately cease distribution of such tobacco product if the 

Secretary finds that there is a reasonable probability that the 

product contains a manufacturing or other defect not 

ordinarily contained in tobacco products on the market that 

would cause serious, adverse health consequences or 

death.

• Section 911(a) of the Act, 21 U.S.C. 387k(a), which prohibits 

any person from introducing or delivering for introduction into 

interstate commerce any modified risk tobacco product 

unless an order issued pursuant to subsection 911(g) is 

effective with respect to such product.

ii. if a person violates a requirement of:

• Section 911(g)(2)(C)(ii) of the Act, 21 U.S.C. 

387k(g)(2)(C)(ii), which requires that an order under section 

911(g) be conditioned on the applicant’s agreement to 

conduct postmarket surveillance and studies and to submit 

to the Secretary the results of such surveillance and studies 

to determine the impact of the order on consumer 

perception, behavior, and health and to enable the Secretary 

to review the accuracy of the determinations upon which the 

order was based in accordance with a protocol approved by

the Secretary.

• Section 911(i)(1) of the Act, 21 U.S.C. 387k(i)(1), which 

requires with respect to a tobacco product for which an 

applicant obtained an order under section 911(g)(1) that the 

applicant conduct postmarket surveillance and studies for 

such a tobacco product to determine the impact of the order 

issuance on consumer perception, behavior, and health, to 

enable the Secretary to review the accuracy of the 

determinations upon which the order was based, and to 

provide information that the Secretary determines is 

otherwise necessary regarding the use or health risks 

involving the tobacco product. The results of postmarket 

surveillance and studies must be submitted to the Secretary 

on an annual basis.

Tobacco Retailers

a. Section 103(q)(2)(A) of the Family Smoking Prevention and Tobacco 

Control Act, Public Law 111-31 (“Tobacco Control Act”) 21 U.S.C. 333 –

Authorizes CMPs against tobacco retailers for violating restrictions 

promulgated under section 906(d) of the Act, including the regulations at 

21 CFR Part 1140. This section provides reduced penalties for retailers 

with an approved training program. At this time, and until FDA issues 
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regulations setting the standards for an approved training program, all 

applicable CMPs will proceed under the reduced penalty schedule.

b. Section 303(f)(8) of the Act, 21 U.S.C. 333(f)(8) – Authorizes imposition 

of a no-tobacco-sale order prohibiting the sale of tobacco products 

against a particular tobacco retail outlet that has committed “repeated 

violations” of restrictions promulgated under section 906(d) of the Act, 

including the regulations at 21 CFR Part 1140. (Section 103(q)(1)(A) of 

the Tobacco Control Act defines “repeated violation” as including at least 

5 violations of particular requirements over a 36-month period at a 

particular retail outlet that constitute a repeated violation). A no-tobaccosale order may be imposed with a CMP.

5-9-2 Reduction Of Civil Money Penalties For Small Entities

The Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA) (Public 

Law 10-121) was enacted on March 29, 1996, and seeks to improve the regulatory 

climate for small entities by, among other things, requiring agencies to establish small 

entity penalty reduction policies.

The FDA may reduce CMPs for small entities as mandated by the SBREFA and the 

Presidential Memorandum of April 21, 1995 (60 FR 20621, April 26, 1995). 

5-9-3 Civil Money Penalty Recommendations

When it is determined that CMP is the appropriate course of action, the Division’s 

Compliance Officer should submit the recommendation package to the appropriate 

Center, except for tobacco retailers.

1. DIVISION RESPONSIBILITIES

The Division recommends a CMP by transmitting to the Center, at a minimum, a 

cover memorandum recommending the action, a draft cover letter to respondents 

and a Complaint accompanied by the supporting evidence.

2. CENTER RESPONSIBILITIES

The Center is responsible for the technical, regulatory, policy and scientific review 

of the Division’s CMP recommendation. Changes to proposed recommendations 

should be made only after discussion with the Division’s compliance staff.

Note: The Center for Tobacco Products (CTP) will initiate CMP actions against 

tobacco retailers.
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NOTE: The Center with jurisdiction over the product under study in an applicable 

clinical trial for which there has been a violation of section 301(jj) of the Act will 

initiate CMP actions under sections 303(f)(3)(A) and 303(f)(3)(B) of the Act.

Approved referrals transmitted to DE should include intact original case files 

organized as submitted from the Division, the Center’s proposed changes to 

respondent letters/Complaint and the Center’s approval memorandum providing 

Center contact information, justification for imposition of civil money penalties and 

other information necessary to review and process the action.

3. DE RESPONSIBILITIES

OSPOP, DE will review the appropriateness of the action and the adequacy of the 

draft cover letter to respondents and Complaint to ensure compliance with existing 

procedures, policies, regulations or statutes. Changes to proposed 

recommendations should be made only after discussion with the Center and the 

Division’s compliance staff.

Approved recommendations to OCC should include DE’s transmittal memorandum, 

DE’s proposed changes to the respondent letters/Complaint and original materials 

submitted by the Division and Center.

4. OFFICE OF CHIEF COUNSEL RESPONSIBILITIES

OCC Approved recommendations will be processed in accordance with procedures 

outlined in 21 CFR Part 17; or, in the case of civil penalties authorized under 

section 307(a) of the Act, in accordance with the procedures in section 307(b) of 

the Act.

5-10 DISQUALIFICATION OF CLINICAL INVESTIGATORS

5-10-1 Purpose

This procedure describes the process, including timeframes, for initiating disqualification 

proceedings – from completion of the inspection to issuance of the Notice of Initiation of 

Disqualification Proceedings and Opportunity to Explain (NIDPOE) to the clinical 

investigator. In addition, it includes the processes and timeframes for follow-up to a 

response to a NIDPOE, through issuance of a Notice of Opportunity for Hearing 

(NOOH).3 This procedure is intended for use by center Bioresearch Monitoring (BIMO) 

Program Units, staff in the Office of the Commissioner (OC), the Office of Regulatory 

Affairs (ORA), and OCC. Adherence to the procedures described in this chapter will 

assist the agency in achieving a uniform approach to the disqualification process.

3 Criteria for initiation of disqualification proceedings are included in the Compliance Program Guidance Manual

(CPGM) 7348.811 for Bioresearch Monitoring: Clinical Investigators, Part V. B.
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5-10-2 Criteria for Initiating Disqualification Proceedings

Criteria for initiating disqualification proceedings are found at 21 CFR 312.70, 511.1(c), 

and 812.119 and are discussed in the clinical investigator CPGM 7348.811. See 

footnote 2. As discussed in t Part V. B.), a decision to initiate disqualification 

proceedings often starts with a decision to classify the EIR as Official Action Indicated 

(OAI).

5-10-3 Initiating the Disqualification Process

When a clinical investigator inspection reveals serious noncompliance, communication 

with the center is essential, as noted in the CPGM 7348.811 Part II, B.3., since 

collection of appropriate supporting evidence is vital. In addition, this will allow the 

center to provide advance notice to OCC and other appropriate offices if it appears a 

recommendation for disqualification may be considered. It is also recommended that the 

division investigator contact the Bioresearch Monitoring Specialist in DE, OSPOP/DE,

ORA who can provide assistance with the process and serve as an additional resource. 

The resulting EIR, with violations indexed to the supporting evidence and exhibits 

appropriately tabbed for easy reference, should be forwarded to the center BIMO 

Program Unit within thirty (30) days of completion of the inspection.

Because center BIMO Program Units need to expeditiously review inspectional findings 

that warrant initiation of disqualification proceedings, center BIMO Program Units should 

review and prioritize within fourteen (14) days of receipt all EIRs with a division office 

recommendation of OAI, with or without a recommendation for clinical investigator 

disqualification. Center BIMO Program Units should review and prioritize EIRs with 

Referred to Center (RTC) designations within a similar timeframe to determine if any 

warrant an OAI designation and therefore possible initiation of disqualification 

proceedings. EIRs with division office recommendations other than OAI or RTC may 

also support initiation of disqualification proceedings. When a BIMO reviewer identifies 

such an EIR, the timeframes discussed below would apply.

Once the potential for initiating disqualification proceedings is identified, the assigned 

BIMO reviewer analyzes the inspectional findings and determines if the findings are 

supported by sufficient evidence of regulatory significance. The BIMO reviewer also 

determines if the division office has received any response to the Form FDA 483 and 

requests a copy of all responses. After reviewing all materials associated with the most 

recent inspection, as well as any information available in the center’s inspectional 

files/databases, the BIMO reviewer drafts his/her rationale for or against initiation of 

disqualification proceedings. Consultation with office/center regulatory personnel and/or 

OCC attorneys during this review may be warranted.

If initiation of disqualification proceedings is not deemed warranted, the BIMO reviewer 

prepares a document explaining that conclusion, for review by his/her supervisor, and 

initiates other appropriate actions. If initiation of disqualification proceedings is deemed 

warranted, the BIMO reviewer prepares appropriate documentation for the 
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administrative record which will support all subsequent steps in the process. The portion 

of the administrative record supporting issuance of a Notice of Initiation of 

Disqualification Proceedings and Opportunity to Explain (NIDPOE) will include such 

documents as:

1. A chart and/or memo summarizing the significant inspectional findings and 

regulatory violations supporting the disqualification action;

2. A chronology/inspectional history of the clinical investigator;

3. A draft NIDPOE (see Exhibit 5-21 for sample); and

3. A draft Consent Agreement (see Exhibit 5-22 for sample)

The NIDPOE file should be appropriately indexed to facilitate review by center 

management, OCC, and ORA. For example, violations cited in the NIDPOE should be 

indexed to the supporting evidence supplied with the EIR. During preparation of the 

NIDPOE file, the BIMO Program Unit should alert all relevant center and Agency offices 

that this file is in preparation to ensure timely review. Review of the NIDPOE file should 

proceed according to center-specific procedures. The NIDPOE file should be ready for 

OCC review within four (4) months from receipt of the EIR. OCC should concur, with 

comments/suggested edits as necessary, or arrange for a discussion with appropriate 

center BIMO personnel if non-concurrence is considered, within four (4) months of 

receipt of the draft NIDPOE.

Upon receipt of OCC concurrence, the BIMO Program Unit incorporates any changes 

and/or additions to the NIDPOE letter and routes the entire NIDPOE file to the 

appropriate center official for signature of the NIDPOE. This signature should be affixed 

within fourteen (14) days of receipt of OCC concurrence. The NIDPOE file and signed 

NIDPOE are returned to the BIMO Program Unit. The BIMO Program Unit should issue 

the signed NIDPOE, with the consent agreement, to the clinical investigator within one 

(1) working day of receipt and distribute copies to the appropriate Agency units, as 

described below.

The NIDPOE directs the clinical investigator to write or call the center, within fifteen 

(15) working days, to arrange for an informal conference or to indicate the intent to 

respond to the allegations in writing. If the clinical investigator chooses to submit a 

written response, the NIDPOE directs him/her to respond within thirty (30) working 

days of receipt of the NIDPOE.

5-10-4 Notice of Initiation of Disqualification Proceedings and Opportunity to

Explain (NIDPOE)

Delivery

A NIDPOE should be sent by certified mail (return receipt requested), or other method 

that documents transmission and receipt of delivery. If such delivery is unsuccessful, 

the center should contact the Director, Investigations Branch (DIB) in the appropriate 
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division office and request that the NIDPOE be hand delivered by Agency personnel. 

The Center will provide the division with addresses and alternative locations for delivery.

Distribution

The issuance of a NIDPOE is a significant regulatory action and appropriate Agency 

units should be promptly advised of its issuance. These include:

[To blind copy electronically, send to the relevant party at

firstname.lastname@fda.hhs.gov; for hardcopy distribution at the White Oak (WO) 

campus, include the building and room numbers] 

OCC; WO31/WO32

DFOI; ELEM-1029

OGCP; WO32-5129

ORA, Division of Enforcement; WO32 [Originating Center - Center files and 

distribution]

[Relevant Division Office - Division Personnel, including the Division Director; the

Director, Investigations Branch; and the Division investigator(s)]

CDER, OSI; WO51

CBER, BIMO Group; HFM-664

CVM, BIMO Group; HFV-234

CDRH, BIMO Group; WO66, BIMO@cdrh.fda.gov

CFSAN, BIMO Group; HFS-205

The Center will forward the NIDPOE to the Center’s FOI program for redaction and 

posting on FDA’s webpage Clinical Investigators - Disqualification Proceedings.

5-10-5 Consent Agreements

After issuance of the NIDPOE, the clinical investigator may choose to enter into a 

consent agreement with FDA. A finalized consent agreement between FDA and the 

clinical investigator terminates the administrative proceedings in this matter. The option 

of entering into a consent agreement with the Agency is available at any time 

throughout the disqualification proceedings, up to the issuance of the Commissioner’s 

Decision under 21 CFR 16.95 or issuance of a notification of disqualification under 21 

CFR 312.70, 511.1(c), or 812.119. The consent agreement may be signed by an FDA 

official as listed in Staff Manual Guide 1410.21- General Redelegations of Authority, 

Paragraph 1.P. As noted above, a sample consent agreement is included in Exhibit 5-

22.

5-10-6 Informal Conference with the Clinical Investigator

In the NIDPOE, the center will offer the investigator the opportunity to submit an 

explanation in writing, or at the investigator's option, in an informal conference. If the 

clinical investigator submits a written response, the regulations do not require the center 

to hold an informal conference, but the center may choose to do so. If an informal 
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conference is requested, the center should schedule it as soon as possible, usually 

within thirty (30) days of the request.

At the informal conference, the clinical investigator may be accompanied by a 

representative of his/her choosing and may provide documents for the record. A clinical 

investigator may submit written materials to FDA within fifteen (15) days after the 

informal conference.

At a minimum, FDA personnel attending the conference will include staff from the center 

BIMO Program Unit and counsel from OCC who reviewed the NIDPOE. FDA may also 

include other personnel with appropriate expertise or relevant experience with the case 

(e.g., a Medical Officer from the review team for the study involved, the FDA division

investigator who conducted the inspection at the clinical investigator’s site). The center 

should make arrangements for the informal conference, notify all pertinent parties of the 

specifics, and arrange to have the discussion transcribed for the administrative record. 

These informal meetings should be scheduled for up to two (2) hours. Because the 

meeting is informal, there is no prescribed format, but the meeting should address all 

allegations listed in the NIDPOE.

Following the informal conference, the center will provide a copy of the written transcript 

to the clinical investigator. The center, in consultation with OCC, should promptly review 

any new explanation or evidence provided by the clinical investigator. If it no longer 

appears that disqualification is warranted, alternatives such as a detailed corrective 

action plan may be considered. The center BIMO Program Unit should notify the clinical 

investigator in writing within thirty (30) days of the informal conference of this decision 

not to proceed with the disqualification and include the specifics of any such alternative 

corrective action plan.

If the clinical investigator's explanation is not accepted by the Center, disqualification is 

still warranted and the center should issue a Notice of Opportunity for Hearing (NOOH) 

to the clinical investigator.

5-10-7 The Notice of Opportunity for Hearing (NOOH)

If a clinical investigator fails to respond to a NIDPOE or the center determines that the 

clinical investigator’s written or oral explanation is inadequate, the regulations provide 

that the clinical investigator be given an opportunity for a regulatory hearing under 21 

CFR part 16 on the question of whether the investigator is eligible to receive test articles 

and eligible to conduct any clinical investigation that supports an application for a 

research or marketing permit for products regulated by FDA. Center BIMO Program 

Units should prepare an NOOH using the sample document provided in Exhibit 5-23. 

The NOOH should be prepared within thirty (30) days of a center’s decision that a 

clinical investigator’s written or oral explanation is inadequate, or after it is clear the 

clinical investigator has chosen not to respond to the NIDPOE. The center should 

consult with OCC during the preparation of the NOOH and clear the NOOH in 
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accordance with center procedures. The center-approved NOOH and the administrative 

record (which includes the NIDPOE file and all follow-up information/documents) should 

be forwarded to OCC for review and clearance. Within thirty (30) working days of 

receipt, OCC should concur or provide comments to the BIMO Program Unit as to what 

is necessary to achieve concurrence with the NOOH.

Within five (5) working days of OCC concurrence, after incorporating any OCC 

additions/changes, the BIMO Program Unit forwards both the paper and electronic 

copies of the NOOH and the administrative record to the Division of Enforcement (DE).

DE has five (5) working days to review and clear the NOOH for signature. If DE, 

during its review, proposes substantive changes to the NOOH, DE will clear their 

proposed changes with OCC, who will consult with the BIMO Program Unit when 

necessary. Within five (5) working days, after clearing any substantive DE 

additions/changes with OCC as necessary (OCC will consult with the Center as 

necessary and notify the center about any changes); DE forwards the NOOH and the 

administrative record to the Associate Commissioner for Regulatory Affairs (ACRA) in 

the ORA for review and signature; and, requests redaction of the NOOH by the Center’s 

FOI office and posting of the redacted NOOH on FDA’s website. The ACRA should sign 

the NOOH, or provide comments to DE as to what is necessary to achieve his/her 

signature, within five (5) working days of receipt. Upon receipt of the signed NOOH 

(within one (1) working day), DE date stamps and issues the NOOH to the clinical 

investigator and/or his/her counsel by certified mail (return receipt requested) or other 

documented method of transmission. If delivery of the NOOH cannot be confirmed, the 

Director, DE, will contact the local division office and request that the NOOH be 

delivered by FDA personnel. The Center will provide the division with addresses and 

alternative locations for delivery. Upon issuance of the NOOH, DE provides a copy of 

the signed NOOH to the center BIMO Program Unit, which is responsible for 

appropriately distributing copies of the NOOH within FDA (see NIDPOE distribution list 

above). The Center will forward the NOOH to the Center’s FOI program for redaction 

and posting on FDA’s webpage, Clinical Investigators - Disqualification Proceedings.

The NOOH provides that the investigator has ten (10) working days from receipt of the

NOOH to request a hearing. If the clinical investigator does not respond within this time 

frame, the clinical investigator will be deemed to have waived the right to a regulatory 

hearing and the Agency will make a decision on the matter based on the facts available 

to the Agency.

DE will advise the center BIMO Program Unit of the response (or lack thereof) to the 

NOOH letter after ten (10) working days. Subsequent actions are discussed and 

determined by the center BIMO Program Unit, OCC, and DE as outlined in the Sample 

Notice of Opportunity for Hearing in Exhibit 5-23. The center BIMO Program Unit is 

responsible for preparing a memo for summary decision regarding the disqualification.

See SMG 7711 for details of the process to be followed after issuance of a NOOH.
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The clinical investigator disqualification proceedings described above are summarized 

in the flowchart found in Exhibit 5-20.
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5-11 EXHIBITS

Exhibit 5-1 Model Section 305 Notice

Exhibit 5-2 Model Charge Sheet

Exhibit 5-3 Model Charges

Exhibit 5-4 Legal Status Sheet

Exhibit 5-5 Information Sheet

Exhibit 5-6 Summary Format - Section 305 Meeting

Exhibit 5-7 Notification of Non-Prosecution

Exhibit 5-8 Timeframes for Administrative Detention of Food (AD of Food) –

Appellant’s Deadlines

Exhibit 5-9 Timeframes for AD of Food – FDA’s Deadlines

Exhibit 5-10 Model General Summary of Information – AD of Food

Exhibit 5-11 Model Comprehensive Statement – AD of Food

Exhibit 5-12 Model Hearing Confirmation Letter – AD of Food

Exhibit 5-13

5-13 A MODEL LETTER – FINAL DECISION ON APPEAL OF 

ADMINISTRATIVE DETENTION ORDER – CONFIRMATION

5-13B MODEL LETTER – FINAL DECISION ON APPEAL OF 

ADMINISTRATIVE DETENTION ORDER – REVOCATION

5-13C MODEL LETTER TERMINATING APPEAL – Administrative 

Detention of Food 

Exhibit 5-14 Model General Summary of Information (Administrative Detention of 

Devices (AD of Devices)

Exhibit 5-15 Model Comprehensive Statement – AD of Devices

Exhibit 5-16 Examples of Detailed Statements – AD of Devices

Exhibit 5-17 Model Hearing Confirmation Letter – AD of Devices

Exhibit 5-18 Model Order – AD of Devices

Exhibit 5-19 Model Order of Retention, Recall, And/Or Destruction

Exhibit 5-20 Disqualification Proceedings Flowchart

Exhibit 5-21 Sample NIDPOE

Exhibit 5-22 Sample Consent Agreement

Exhibit 5-23 Sample Notice of Opportunity for Hearing (NOOH)
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Exhibit 5-1 MODEL SECTION 305 NOTICE

In reply refer to: Sample No. Product

Firm Name and Individual Date

Street Address

City, State, Zip

Investigation by this Administration indicates your responsibility for violations of the Federal 

Food, Drug, and Cosmetic Act, and other Federal Laws, as described in the attached 

Charge Sheet, with respect to the following:

Shipment of an article labeled in part "Cream Style White Sweet Corn Net Weight 5 lb 10 

oz" by (Firm, Location), to (Firm, Location), on or about (date).

A meeting has been scheduled for (day, date, time) at (location), to give you an opportunity 

to present your views on this matter. The enclosed INFORMATION SHEET explains the 

purpose and nature of the meeting, and how you may reply. If no response is received on 

or before the date set, our decision on whether to refer the matter to the Department of 

Justice for prosecution will be based on the evidence in hand.

By direction of the Secretary of the Department of Health and Human Services:

/s/

Compliance Officer

(IMPORTANT: NOTE ALL ENCLOSURES CAREFULLY)

Enclosures:

Legal Status Sheet (3) Charge Sheet Information Sheet Regulations
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Exhibit 5-2 MODEL CHARGE SHEET

CHARGE SHEET

(In Connection with Enclosed Section 305 Notice) 

Sample Nos. Sample Nos.

Sample #, Product Sample #, Product 

Sample #, Product Sample #, Product 

Sample #, Product Sample #, Product 

Sample #, Product Sample #, Product 

Sample #, Product Sample #, Product 

Sample #, Product Sample #, Product

PROHIBITED ACT: Section 301(a) of the Federal Food, Drug, and Cosmetic Act. The 

introduction or delivery for introduction into interstate commerce of 

any food that is adulterated.

CHARGES: The articles are adulterated in the following respects: Sample #)

Sample #)

Sample #)

Sample #) They contain insect fragments and rodent hair fragments. Sample #)

Sample #) Sample #) Sample #) Sample #)

Sample #) It contains insects, insect fragments, and rodent hair fragments. 

Sample #) It contains insect fragments.

Sample #) It contains insect larvae, insect fragments, and rodent hair fragments.

All Samples) The factory in which the articles were prepared was infested with 

insects and rodents which may have contaminated the articles 
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Exhibit 5-3 MODEL CHARGES

SPECIMEN CHARGE

(Do not quote the section of the Act listed below on the Charge Sheet)

Adulterated Foods

402(a)(1)

• The soybeans contain an added poisonous or deleterious substance, namely, 

crotalaria seeds, which may render them injurious to health.

• The frozen eggs contain added salmonella microorganisms, pathogenic bacteria, 

which may render them injurious to health.

• The article contains selenium, a poisonous or deleterious substance, in a 

quantity that would ordinarily render it injurious to health.

402(a)(2)(A)

• The articles contain an added deleterious substance, namely, metal fragments, 

which is unsafe since it is not required in the production of this food and can be 

avoided by good manufacturing practices.

• The cod fillets contain oxytetracycline that is unsafe, since oxytetracycline is not 

required in the production of this food and can be avoided by good 

manufacturing practices.

NOTE: Generally, the use of Section 402(a)(2)(A) as a basis for charges should be limited; 

other sections, such as 402(a)(1), are usually preferred.

402(a)(2)(B)

• The berries contain heptachlor, which is not generally recognized as safe, and 

for use of which a tolerance has not been prescribed by regulation.

• The cabbage contains excessive Toxaphene.

402(a)(2)(C)

• The article contains a food additive, namely lead, which is unsafe within the 

meaning of Section 409(a) since its use and intended use are not in conformity 

with a regulation or exemption in effect.

402(a)(2)(D)

• The meat intended for human food contains a new animal drug, namely MGA, 

which is unsafe in that there is no approved new animal drug application in effect 

for this use.

402(a)(3)

• The article contains insect parts and insect excreta.
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• The article contains rodent excreta pellets.

• The nuts are rancid.

• Some of the cans contain decomposed salmon.

• The catsup contains decomposed tomatoes 

• The peanut butter contains grit.

402(a)(4)

• The factory (warehouse) in which it was prepared and packed (held) was 

infested with rodents and insects, which may have contaminated it.

402(a)(5)

• Some of the boxes contain emaciated and diseased birds.

• Some of the boxes contained birds that were not slaughtered but that died from 

other causes.

402(a)(7)

• The article has been subjected to radiation, not provided for by the Food 

Additives Regulations.

402(b)(1)

• The article is deficient in Vitamin B.

• The butter contains less than 80% milkfat.

402(b)(2)

• Mineral oil has been used to replace part of the vegetable oil.

• Chicory has been used in part instead of coffee.

402(b)(3)

• Blemished, old potatoes have been colored and waxed to resemble new 

potatoes and to conceal the blemishes.

402(b)(4)

• The ground pepper contains ground olive seeds.

• The poppy seeds are brown and have been artificially colored to appear to be 

blue poppy seeds.

402(c)

• The article contains a color additive, namely, "butter yellow," not permitted by 

regulation for use in food.

• The article contains a color additive, namely, FD&C Purple Number 8, for which 

no tolerance has been established 
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402(d)

• Some pieces of the candy contain a metallic toy.

• The candy is filled with alcohol 

402(e)

• The article contains vegetable oil that is rancid.

• The milk used to manufacture the butter contained flies and manure 

Misbranded Foods

403(a)

• The label falsely represents it to contain a significant amount of honey but the 

amount present, if any, is inconsequential.

• The label bears statements that falsely represent, in the setting in which they are 

presented, that the article will supply an unusually large amount of protein in a 

quantity which is low in calories, and that the article is therefore of significant 

value for weight reducing.

• The labeling falsely represents that the product contains copper, folic acid, cobalt 

and calcium pantothenate.

• The label falsely represents the article to be canned peas, whereas the article is 

canned spinach 

403(b)

• It was offered as lemon extract by the price list sent to the consignee on or about

• May 2, XXXX, but it is in fact an extract of lemon grass oil 

403(c)

• The word "Imitation" on the label is in type of smaller size and less prominence 

than the type in which the words "Vanilla Extract" appear.

• The label fails to bear the name "Imitation Strawberry Preserves."

403(d)

• The can has a depressed top and bottom and contains a thick corrugated inner 

liner, which give the container the appearance of containing more nuts than it 

does.

• The container is slack-filled 

403(e)(1)

• The label fails to bear the name of the manufacturer, packer, or distributor.

403(e)(2)

• The label statement "net weight 4 oz." is inaccurate.
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• The article is short weight.

403(f)

• The statement of ingredients on the label is inconspicuous.

• The name and address of the manufacturer is printed on the cellophane bag in 

white ink and lacks contrast with the white candy mints contained therein 

403(g)(1)

• The article is represented as raspberry preserves but contains less fruit than the 

standard of identity requires.

• The article purports to be French dressing but contains less fat than specified in 

that standard.

• The egg noodles are deficient in egg solids content 

403(g)(2)

• The article is bleached flour but the label does not state that it is bleached.

• The article purports to be enriched macaroni, and its label fails to bear the name 

of that food.

• The article purports to be Fruit Butter, but its label fails to bear the name of the 

optional ingredient, lime juice, present in the food.

403(h)(1)

• The article contains excessive blemished fruit but its label does not bear the 

statement of substandard quality prescribed for canned peaches.

• Its quality falls below the standard for canned tomatoes, since it contains 

excessive peel.

403(h)(2)

• The cans are underfilled but the label does not bear the statement of 

substandard fill prescribed for canned peas.

403(i)(1)

• The article is ground cinnamon but its label does not bear the name "ground 

cinnamon."

403(i)(2)

• Flour is present but is not named in the label listing of ingredients.

• The label fails to bear a statement of ingredients of the article by their common 

or usual names.
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403(j)

• Its label fails to bear a statement of the percentage of the USRDA for the 

vitamins B(1), B(2), niacinamide and the mineral iron, as required by the special 

dietary regulations.

• The label fails to state the percent by weight of methylcellulose present; and in 

juxtaposition with name of such constituent, the word "non-nutritive," as required 

by the special dietary regulations 

403(k)

• The labeling fails to state the fact that a chemical preservative has been added.

• The article is artificially colored, but its labeling fails to state that fact 

403(l)

• The oranges contain biphenyl (diphenyl applied post harvest), but its shipping 

container fails to bear labeling declaring the name and function of the pesticide 

chemical 

403(m)

• The article is a color mixture but its label does not declare the name of the color 

components contained therein 

Adulterated Drugs

501(a)(1)

• The aspirin tablets contain rodent hairs.

501(a)(2)(A)

• The plant in which the aspirin tablets were manufactured was infested with 

rodents which may have contaminated them.

501(a)(2)(B)

• The door of the sterile filling room was left open while filling bottles of an eye 

solution.

• The methods used in its packing do not conform to current good manufacturing 

practices in that Isopropyl alcohol is labeled as Citrate of Magnesia.

501(a)(3)

• Its container is composed in part of lead, which may render the contents 

injurious to health.

501(a)(4)(A)

• The color used is in excess of the limits prescribed in the regulations.
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501(a)(4)(B)

• FD&C Red #4 intended for use in a drug for internal administration, and such 

use is for coloring purposes only.

501(a)(5)

• The article is a new animal drug and there is no approved new animal drug

application in effect for this drug.

501(a)(6)

• The cattle feed contains a new animal drug, namely Carbadox, which is unsafe 

in that there is no approved new animal drug application in effect for this use.

501(b)

• The article purports to be an official NF drug but fails to comply with the 

compendium's standard for strength.

• It contains cresol, a substance not permitted by the U. S. Pharmacopeia

Monograph for Water for Injection, which the drug purports to be.

• Magnesium carbonate, which the NF formula requires in Solution of Magnesium

• Citrate, has been replaced by sodium carbonate 

501(c)

• The article contains Neomycin Sulfate which is below the potency declared on 

the label.

• The quality of the article namely, Rubber Prophylactics, falls below that which it 

is purported to possess 

501(d)(1)

• The article has been mixed or packed so as to reduce its quality or strength.

501(d)(2)

• P-aminosalicylic acid has been substituted in part for conjugated para-amino 

salicylic ascorbate.

Misbranded Drugs

502(a)

• Its labeling represents it as a treatment for influenza and related diseases, but it 

is not an effective treatment for these diseases.

• The article falsely claims that it will remove ascarids from hogs 
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502(b)(1)

• Its label does not bear the name and place of business of the manufacturer.

502(b)(2)

• Its label does not bear an accurate statement of the quantity of contents.

502(c)

• The statement "24 tablets" appears on the back label and is on a pink label in 

red type 

502(e)(1)(A)(i)

• The label does not show that the drug is aspirin.

502(e)(1)(A)(ii)

• The quantity of bromide per tablet is not stated on the label.

• Its label fails to list all of the active ingredients.

502(f)(1)

• The directions do not state the uses of the drug.

• Its (O-T-C drug) labeling does not contain directions adequate for the treatment 

of diabetes, for which use the drug is recommended in advertising (as 

distinguished from labeling).

• The prescription drug lacks adequate full disclosure information.

502(f)(2)

• The labeling does not warn against use of the drug in case of nausea, vomiting, 

abdominal pain, or other symptoms of appendicitis.

• The labeling gives no warning that use of the drug in excess of what the 

directions call for may result in nervousness and sleeplessness.

502(g)

• It is not packaged in tight containers as required by the United States 

Pharmacopoeia 

502(i)(1)

• The container is slack-filled.

502(i)(2)

• It is an imitation of citrate of magnesia.

502(i)(3)

• The article, namely argel leaves, is offered for sale as senna.
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502(j)

• It is dangerous to health when one tablet is taken every three hours as 

recommended in the labeling.

• It is dangerous to health when taken in the dosage suggested in its labeling 

502(m)

• The label fails to provide directions for use to preclude adding excessive color 

additive to the drug.

502(n)(1)

• The advertisement for Miltown which appeared in the May 19, 20XX edition of 

the Pleasant Medical Journal did not show the established name.

502(n)(2)

• • The advertisement for "Triple Sulfa" tablets which appeared ______ etc. did 

not list the active ingredients by their established names.

502(n)(3)

• The advertisement for "Triple Sulfa" tablets which appeared in the May 19, 20XX 

edition of contained or recommended indications for use or a dosage 

recommendation, but not the brief summary of side effects, contraindications, 

and effectiveness.

502(o)

• The potassium chloride tablets were manufactured in an unregistered plant 

503(b)(4)(A)

• The label for the article, namely chloralhydrate, does not bear the symbol “Rx 

only”.

503(b)(4)(B)

• • The aspirin tablet label bears the symbol “Rx only,” but the drug is not 

entitled to such designation.

505(a)

• The article, namely, Meprobamate, is a new drug and was shipped in interstate 

commerce without an approved new drug application 
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Cosmetics

601(a)

• The article contains paraphenylenediamine, a coal tar dye which is a deleterious 

substance, but its label does not carry adequate warnings or directions to make 

a preliminary patch test before use.

• It contains formaldehyde, a deleterious substance.

601(b)

• Some of its components contain rodent excreta pellets 

601(c)

• The plant in which the article was prepared was infested with rodents 

601(d)

• Its container is composed in part of lead 

601(e)

• The color used is not authorized by the regulations (or is in excess of the limits 

prescribed in the regulations.)

602(a)

• The article is represented as containing a substantial amount of lanolin, but 

lanolin is a minor constituent of the cream 

5-1-2

602(b)(1)

• The label for the eye shadow does not bear the name and location of the 

manufacturer, namely, New York Pencil Co., Inc., New York, N.Y.

602(b)(2)

• The article does not bear a statement of the quantity of contents.

602(c)

• The statement of the quantity of contents appears on the bottom of the container 

(oval jar) 

602(d)

• The nontransparent container is composed of an outer and inner wall with a 1/8 

inch space between the walls 
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602(e)

• The label fails to provide directions for use to preclude adding excessive color 

additive to the cosmetic 

Title 42

351(a)

• The Source Plasma (Human) was drawn and shipped from an unlicensed 

establishment.

• The label fails to bear the expiration date and license number of the 

establishment 

351(b)

• The label states the blood is Hgb negative, but the records show the unit is Hgb 

positive.

• The donor number on the unit label is false.

• The product is pooled serum, but the label falsely states it was drawn from one 

donor 

351(c)

• Inspection of the establishment by a duly authorized investigator was refused 

351(e)

• Officers of your firm interfered with the investigator in the performance of his 

duties by refusing to provide necessary records for his review 

Title 18, Section 1001

• The firm was aware that test animals had died, but concealed that fact.

• You advised FDA Investigators that you had no connection with the study, 

knowing the statement to be false.

• The study that was submitted with NDA 80-125 contains fictitious entries.

• The documents submitted in support of your application contain false 

statements.
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Exhibit 5-4 LEGAL STATUS SHEET

SAMPLE NO: _____________________________

A. STATUS OF FIRM AT TIME OF ALLEGED VIOLATIONS

Date ___________

Full name of firm ________________________________________________

Please check and fill in appropriate section below:

1. Corporation Year Incorporated _____ Under laws of what state? _____

Names and Titles of principal officers

______________________________________________________________

(include first name and middle initial)

2. Partnership 

Name of each partner

______________________________________________________________

(include first name and middle initial)

3. Sole Ownership 

Name of Owner

______________________________________________________________

(include first name and middle initial)

B. STATUS OF FIRM AT PRESENT TIME

Date: _______

Same as above  Different 

Full name of firm ______________________

1. Corporation  Year Incorporated ____Under laws of what state? ____
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Names and titles of principal officers

______________________________________________________________

(include first name and middle initial)

2. Partnership

Name of each partner

______________________________________________________________

(include first name and middle initial)

3. Sole Ownership

Name of Owner

______________________________________

(include first name and middle initial)

Signature ___________________________

Title ________________________________
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Exhibit 5-5 INFORMATION SHEET

DEPARTMENT OF HEALTH AND HUMAN SERVICES

PUBLIC HEALTH SERVICE

FOOD AND DRUG ADMINISTRATION

INFORMATION SHEET IN CONNECTION WITH ENCLOSED SECTION 305 NOTICE

OBJECT OF THE MEETING

This meeting is scheduled to give the person or persons who appear to be responsible for 

the violations of the Federal Food, Drug, and Cosmetic Act, and other Federal Laws, as 

specified in the attached Charge Sheet an opportunity to explain voluntarily any 

circumstances connected with the preparation, handling, shipment, or sale of the articles 

involved which would indicate that criminal action should not be taken. You are not 

compelled, however, to answer. Any civil action which may have been taken against the 

goods involved, such as seizure, does not preclude prosecution of those responsible for 

the violation: the meeting concerns the possible criminal action only. A copy of the Federal 

Food, Drug, and Cosmetic Act and regulations for its enforcement may be had upon 

request.

NATURE OF THE MEETING

This meeting is informal and confined to questions of fact. For your convenience in 

submitting required information concerning the status of your firm both on the date of 

response to this notice and on the date of alleged violation, the attached Legal Status 

forms may be filled out and returned with your answer, whether written or by personal 

appearance. Your answer may consist of the disclosure of any pertinent facts, letters, files, 

guaranties, shipping documents, analyses, arguments, etc., which you feel may present 

valid reasons why you should not be prosecuted.

GUARANTIES

In the case of articles that are adulterated or misbranded when introduced in interstate 

commerce the Federal Food, Drug, and Cosmetic Act (the Act) places responsibility on the 

interstate shipper, even though he may be only the distributor and not the manufacturer. 

Distributors may relieve themselves of responsibility if they hold a legal guaranty under 

Section 303(c) of the Act. If the articles were sold to you by a person residing in the United 

States and guaranteed by such person to comply with the provisions of the Act, you should 

submit:

• Evidence of that fact, and

• A statement as to whether the product at the time of the apparent violation by 

you was in the identical condition and bore the same labels as when received by 

you from the guarantor, and
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• The full name of the person who, if called upon, can identify the pertinent records 

and testify to the facts as you present them.

HOW TO ANSWER

You may appear in person or by attorney or other designated representative, or you many 

submit your response in the form of a letter in lieu of personal appearance. If written 

response is made, please submit your letter and all accompanying documents in triplicate. 

Documents submitted at personal appearance should be in triplicate. All documents 

should be conspicuously identified by the reference number shown on the upper 

right corner of the Section 305 Notice.

RESULT OF THE MEETING

After the meeting has been held and all the facts considered, if it is the conclusion of the 

Secretary of the Department of Health and Human Services that prosecution should be 

recommended, the facts in the matter will be transmitted to the Department of Justice for 

appropriate action.

FORM FDA 466a (7/80) PREVIOUS EDITION IS OBSOLETE.
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Exhibit 5-6 SUMMARY FORMAT - SECTION 305 MEETING

SUMMARY

FIRM AND INDIVIDUAL CITED: SAMPLE NO. AND PRODUCT:

_____________________________________________________________

DATE OF MEETING:

WHERE HELD:

_____________________________________________________________

PRESENT:

(List attendees - name, title, etc.)

_____________________________________________________________

WRITTEN SUMMARY

Compliance Officer________________________

__________ Division

(distribution)
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Exhibit 5-7 NOTIFICATION OF NON-PROSECUTION

Dear_____________________________:

Pursuant to 21 CFR 7.85(h), this is to advise you of the decision not to proceed with 

criminal prosecution of (firm name and/or individual name or names) based on the charges 

set forth in the Section 305 Notice dated .

This decision is based on the evidence we have at this time and does not preclude the 

initiation of criminal prosecution, based in whole or in part on any or all of the charges set 

forth in the Notice, should new evidence or subsequent violations of the law reveal the 

need for such action. In such case, a new Section 305 Notice will issue except as provided 

in 21 CFR 7.84(a)(2) and (3)

______________________________________

Division Director
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EXHIBIT 5-8 DEADLINES FOR ADMINISTRATIVE DETENTION OF FOOD

Appellant’s Deadlines 

Action Perishable Food Non-perishable Food

Requesting a

Hearing

Two (2) calendar days

Request for hearing must be included 

in request for appeal.

Four (4) calendar days

Notice of intent to request a hearing 

must be filed within four (4) calendar 

days of receipt of detention order—or 

FDA will not grant the hearing.

Request for hearing must be filed 

within ten (10) calendar days from 

receipt of detention order.

Filing an

Appeal

Two (2) calendar days

Appeal must be filed within two (2)

calendar days of receipt of detention 

order (the appeal may or may not 

include a request for a hearing)

Ten (10) calendar days

Appeal must be filed within ten (10)

calendar days of receipt of detention 

order.
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EXHIBIT 5-9 TIMEFRAMES FOR ADMINISTRATIVE DETENTION OF FOOD

FDA’s Deadlines

Holding a Hearing Two 2 calendar days

If the Appeal includes a request for a hearing, and FDA grants the request, 

the hearing must be held within two (2) calendar days after the date the 

appeal is filed.

Written Report of

the Hearing

Noon of the fifth (5th) calendar day

The presiding officer must issue a written report that includes a proposed 

decision confirming or revoking the detention by noon on the fifth (5th) 

calendar day after the appeal is filed. The hearing participants have four (4) 

hours to submit comments. The presiding officer must issue a decision on the 

appeal within five (5) calendar days after the appeal is filed. [See “Decision 

on an Appeal (with or without a hearing)” below]

Decision on an

Appeal (with or 

without a hearing)

Five (5) calendar days

If a detention order is appealed, the presiding officer must issue a decision on 

the appeal confirming or revoking the detention within (five) 5 calendar days 

after the appeal is filed. If the presiding officer fails to confirm or terminate the 

detention order within this time frame, the detention is deemed terminated.

Seizure of

Perishable Foods

Four (4) calendar days to send recommendation to DOJ

If FDA initiates a seizure action against Perishable Food, FDA will send the 

seizure recommendation to the Department of Justice within four (4) calendar 

days after the detention order is issued, unless extenuating circumstances 

exist. If the fourth (4th) calendar day is not a working day, OCC must advise 

DOJ on the last working day before the deadline of its plans to recommend a 

seizure and will send the seizure as soon as practicable on the first working 

day after the non-work day.
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Exhibit 5-10 MODEL GENERAL SUMMARY OF INFORMATION – Administrative 

Detention of Food*

[Division Letterhead]

Date

Mr. John E. Smith

XYZ, Inc.

123 Smith Lane

Anywhere, MS 

RE: Administrative Detention Order DO [insert #]

Dear Mr. Smith:

Pursuant to section 16.24(f) of Title 21 of the Code of Federal Regulations (21 CFR 

16.24(f)), this letter provides notice of matters to be considered at the hearing 

requested as part of your appeal of administrative detention order DO [insert #]. As 

authorized under section 304(h) of the Federal Food, Drug, and Cosmetic Act (Act), the 

U.S. Food and Drug Administration (FDA) administratively detained [insert description 

of food] located at [insert location] on [insert date] because the Agency has reason 

to believe that the food is [adulterated or misbranded]. You may find the Act and its 

implementing regulations through links on FDA’s home page at www.fda.gov.

[If the administrative detention is based, in whole or in part on CLASSIFIED 

information, consult with OCC on the classified information and insert the following: 

FDA’s decision to administratively detain the food is based [in whole or in part] 

on classified information. In accordance with 21 CFR 1.406, FDA will not provide 

you with this information. [Insert a statement about the general nature of our 

basis for the detention, if the classified information and its source can be 

safeguarded.]

[If the administrative detention is not based on CLASSIFIED information, insert the 

following:

FDA’s decision to administratively detain your food is based on the following 

information:

[Insert a comprehensive statement of the basis for the administrative 

detention, including applicable misbranding or adulteration charges. Also 

provide a general summary of the information that FDA will present at the 

hearing in support of the administrative detention.

Examples of sources of supporting information for the summary include, but 

are not limited to:
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1. Form FDA 483 Inspectional Observations that documents 

objectionable conditions or practices

2. Establishment Inspection Report (EIR) including Exhibits, which 

describe, in detail, objectionable conditions or practices observed, 

including product manufacturing information, responsible individuals, 

and documents collected

3. Sample information including Collection Reports and analytical results 

or data analysis

4. The food label and labeling

5. Affidavits relating to the adulteration or misbranding

6. Records (e.g., supplier, manufacturer, and distribution records)

7. Epidemiological data from Centers for Disease Control and Prevention 

or other public health officials that establishes an association between 

the detained food with foodborne illness

8. Reportable food reports]

If you have any questions regarding information in this letter, you may contact me at 

[Division Director’s phone number] prior to the hearing.

Sincerely yours,

Division Director
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Exhibit 5-11 MODEL LETTER GRANTING HEARING – Administrative Detention of 

Food

[Division/OE Letterhead]

Date

Mr. John E. Smith

XYZ, Inc.

123 Smith Lane

Anywhere, MS 

RE: Administrative Detention Order DO [insert #]

Dear Mr. Smith:

I am confirming the information discussed during our telephone conversation today 

regarding the hearing you requested in your appeal of the administrative detention of 

[insert description of food] located at [insert location].

I am granting your request for a hearing and providing additional information about the 

hearing. The hearing you requested will be held on [insert date] at [insert time] at the 

[insert Division Office, street address, city, state, and Zip Code].

The hearing will be a closed hearing because the proceedings constitute an open 

investigatory record (21 CFR 16.60(a)). This means that only you, your counsel, witnesses, 

and employees as well as FDA representatives will be allowed to attend.

Under 21 CFR 1.403 a hearing on appeal of a detention order shall be conducted in 

accordance with 21 CFR part 16 – Regulatory Hearing Before the Food and Drug 

Administration with the following exceptions:

1. The detention order under 21 CFR 1.393, rather than the notice under 21 CFR 

16.22(a), provides notice of opportunity for the hearing and is part of the 

administrative record of the regulatory hearing under 21 CFR 16.80(a).

2. A request for a hearing must be addressed to the FDA Division Director in whose 

division the article of food involved is located.

3. The provision in 21 CFR 16.22(b), providing that a person not be given less than 

three (3) working days after receipt of notice to request a hearing, does not 

apply.

4. The provision in 21 CFR 16.24(e), stating that a hearing may not be required to 

be held at a time less than two (2) working days after receipt of the request for a 

hearing, does not apply.

5. 21 CFR 1.406, rather than 21 CFR 16.24(f), describes the statement that will be 

provided to an appellant where a detention order is based on classified 

information.
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6. 21 CFR 1.404, rather than 21 CFR 16.42(a), describes the FDA employees, e.g., 

Division Directors or other officials senior to a Division Director, who preside at 

hearings.

7. The presiding officer may require that the hearing be completed within one (1)

calendar day, as appropriate.

8. 21 CFR 16.60(e) and (f) do not apply to the hearing. The presiding officer must 

prepare a written report of the hearing. All written material presented at the 

hearing will be attached to the report. The presiding officer must include as part 

of the report of the hearing a finding on the credibility of witnesses (other than 

expert witnesses) whenever credibility is a material issue, and must include a 

proposed decision, with a statement of reasons. The hearing participant may 

review and comment on the presiding officer's report within 4 hours of issuance 

of the report. The presiding officer will then issue the final Agency decision.

9. 21 CFR 16.80(a)(4) does not apply to the hearing. The presiding officer's report 

of the hearing, and any comments on the report by the hearing participant under 

21 CFR 1.403(h), are part of the administrative record.

10. No party shall have the right under 21 CFR 16.119 to petition the Commissioner 

of Food and Drugs for reconsideration or a stay of the presiding officer's final 

Agency decision.

11. If FDA grants a request for an informal hearing on an appeal of a detention 

order, the hearing must be conducted as a regulatory hearing pursuant to 

regulation in accordance with 21 CFR part 16, except that 21 CFR 16.95(b) does 

not apply to the hearing. With respect to the regulatory hearing on an appeal of a 

detention order, the administrative record of the hearing specified in 21 CFR 

16.80(a)(1), (a)(2), (a)(3), and (a)(5), and 1.403(i) constitutes the exclusive 

record for the presiding officer's final decision on an administrative detention. For 

purposes of judicial review under 21 CFR 10.45, the record of the administrative 

proceeding consists of the record of the hearing and the presiding officer's final 

decision.

I am authorized by 21 CFR 10.19 and 21 CFR 16.60(h) to waive, modify, or suspend any 

provision under 21 CFR part 16. I am modifying 21 CFR 16.60(b), which provides that all 

parties may confront and conduct reasonable cross-examination of any person (except for 

the presiding officer and counsel for the parties) who makes any statement on the matter 

at the hearing. Reasonable questioning will be allowed instead.

If feasible, at least one (1) day before the hearing, you are to provide the Division Director 

with written notice of, or a copy of, if the Division Director could not reasonably be 

expected to obtain a copy, any published articles or written information that you intend to 

present or rely upon at the hearing, as required by 21 CFR 16.24(g). You may provide this 

information by facsimile: [insert number], electronically: [insert e-mail], or courier: [insert 

name and address of Division Director].
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Any written communication you forward or present to me must be sent by you to all other 

participants to the hearing as required by 21 CFR 16.44(c).

You are requested to provide at the hearing a brief summary of any lengthy documents 

you intend to present at the hearing.

If you have any additional questions on the procedures I will follow at the hearing, you may 

contact me at [insert phone number] prior to the hearing.

Sincerely yours,

[Presiding Officer]
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Exhibit 5-12 MODEL LETTER DENYING HEARING – Administrative Detention of 

Food

(Division/OE Letterhead) 

Date

Mr. John E. Smith

XYZ, Inc.

123 Smith Lane

Anywhere, USA 

RE: Administrative Detention Order DO [insert #]

Dear Mr. Smith:

This is a follow-up to our telephone conversation today regarding the hearing you 

requested as part of your appeal of the administrative detention of [insert description of 

food] located at [insert location]. 

I am denying your request for a hearing because you have not raised a genuine and 

substantial issue of fact (21 CFR 16.26(a)). Specifically, [insert reason why no genuine 

and substantial issue of fact was raised by the appellant].

Sincerely yours, Presiding Officer
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Exhibit 5-13A

MODEL LETTER – FINAL DECISION ON APPEAL OF ADMINISTRATIVE DETENTION 

ORDER – CONFIRMATION 

Administrative Detention of Food

[Division/OE Letterhead]

Date

Decision on Appeal –Confirmation

Administrative Detention Order DO [insert #]

Mr. John E. Smith

XYZ, Inc. 

123 Smith Lane

Anywhere, MS

Dear Mr. Smith:

I am confirming the administrative detention order for [insert description of food] located 

at [insert location] because [insert reason why confirming detention].

[If information that supports the administrative detention is, in whole or in part, 

CLASSIFIED information, insert the following:] 

My decision is based [in whole or in part] on classified information.

[If information that supports the administrative detention is not CLASSIFIED information, 

insert the following:]

My decision is based on information you submitted in your appeal [and information 

presented by all parties at the hearing on the appeal].

The administrative detention is effective until [insert date], unless FDA issues a detention 

termination notice prior to that date. It is a prohibited act under section 301(bb) of the 

Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 331(bb), to move an article of food that 

is subject to administrative detention or to alter or remove any mark or label that identifies 

the article of food as administratively detained.

Sincerely yours,

[Presiding Officer]
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Exhibit 5-13B

MODEL LETTER – FINAL DECISION ON APPEAL OF ADMINISTRATIVE DETENTION 

ORDER – REVOCATION

Administrative Detention of Food

[Division/OE Letterhead]

Date

Decision on Appeal – Revocation

Administrative Detention Order DO [insert #]

Mr. John E. Smith

XYZ, Inc. 

123 Smith Lane

Anywhere, MS

Dear Mr. Smith:

I am revoking the administrative detention order for [insert description of food] located at 

[insert location] because [insert why the order is being revoked]. The administrative 

detention is terminated as of this date and the food is released. You may remove the labels 

and tags relating to the detention and return the tags to the Division Director. 

[If information utilized to support the administrative detention is, in whole or in part, 

CLASSIFIED information, insert the following:] 

My decision is based [in whole or in part] on classified information.

[If information utilized to support the administrative detention is not CLASSIFIED

information, insert the following:]

My decision is based on information you submitted in your appeal [and at the 

hearing on the appeal]. Thus, FDA no longer has reason to believe the food is 

adulterated or misbranded.

Sincerely,

[Presiding Officer]
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Exhibit 5-13C

MODEL LETTER TERMINATING APPEAL – Administrative Detention of Food 

[Division/OE Letterhead]

Date

Mr. John E. Smith 

XYZ, Inc. 

123 Smith Lane

Anywhere, USA 

RE: Administrative Detention Order DO [insert #]

Dear Mr. Smith:

Your appeal of the administrative detention of [insert description of food] located at [insert 

location] has been terminated because a [seizure action under section 304(a) of the 

Federal Food, Drug, and Cosmetic Act or an injunction under section 302 of the Federal 

Food, Drug, and Cosmetic Act] has been filed in court regarding the article of food involved 

in the detention order (21 CFR 1.402(c)) ([name of case]).

If you have any questions on this termination of your appeal, you may contact the Division

at [insert phone number].

Sincerely yours,

[Presiding Officer]
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Exhibit 5-14

MODEL GENERAL SUMMARY OF INFORMATION Administrative Detention of 

Devices

Division Director Letterhead

Date

Ace Plastic Company

11124 Railroad Street

Ogallala, Nebraska 69158

Dear Sir:

This is a General Summary of Information in Support of Detention DN 60011. We intend to 

present the following information to support our action:

1. Form FDA 483 list of observations issued to Albert C. Edwards, owner of Ace Plastic

Company.

2. Establishment Inspection Report dated February 20, 1980.

3. Collection Report for sample of syringes.

4. Pages from Quality Control Log of Ace Plastic Company dated February 18, 1980.

5. Testimony of Sidney H. Rogers, Investigator, reporting his observations and his 

discussion with Mr. Edwards.

Sincerely yours, Division Director
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Exhibit 5-15

MODEL COMPREHENSIVE STATEMENT* Administrative Detention of Devices

Date

Ace Plastic Co.

11124 Railroad Street

Ogallala, Nebraska 69150

Dear Sir:

The following is a Comprehensive Statement of the Basis for Detention Order DN 60011. 

FDA Investigator _______ observations:

Black unidentified spots on the needles and holes in the individual protective 

packaging of the sterile 2cc syringe led him/her to believe that the devices are 

adulterated and misbranded resulting in issuing Detention Order number DN 60011

made these observations during his/her (date) inspection of your establishment.

The black spots on the needles and holes in the packages lead us to believe the product is 

adulterated within the meaning of (1) Section 501(a)(2)(A) of the Federal Food, Drug, and

Cosmetic Act (the Act) in that the device has been prepared, packed, or held under 

insanitary conditions whereby it may have been rendered injurious to health; and (2) within 

the meaning of Section 501(c) of the Act in that its quality falls below that which it purports 

or is represented to possess. Further, these same observations lead us to believe that the 

product is misbranded per Section 502(a) of the Act because the label states the product 

to be sterile and the holes in the protective wrapper allow the product to be exposed to 

contamination.

*To be used when the detention order (FDA 2289 Detention Notice) may not serve as the 

Comprehensive Statement because the "reason for detention" is not described in sufficient 

detail. When the detention order may serve as the Comprehensive Statement, the letter 

need only include a copy of the detention order and reference the "reason for detention" as 

the Comprehensive Statement.
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Exhibit 5-16

EXAMPLES OF DETAILED STATEMENTS Administrative Detention of Devices

EXAMPLES OF STATEMENTS UNDER ITEM #15, "REASON FOR DETENTION" THAT 

PROVIDE SUFFICIENT DETAIL FOR THE FDA 2289 ORDER TO SERVE AS A 

COMPREHENSIVE STATEMENT:

1. 21 USC Section 351(c) charge.

- Detention order cites adulteration within the meaning of Section 351(c) because the 

quality of the device falls below that which it claims to possess.

- Comprehensive statement expands upon the charge in the detention order by adding: 

"...because the labeling specifies that the device measures "x" within + 3 percent but tests 

conducted by FDA show that the device only measures "x" within + 25 percent.”

2. 21 USC Section 351(h) charge.

- Detention order cites adulteration within the meaning of Section 351(h) in that the 

methods used in, etc. (tracking in plain language the applicable portion of the statute) are 

not in conformity with GMP requirements under 21 USC Section 360j(f) as set forth in 21 

CFR Part 820.

- Comprehensive Statement expands upon the charge in the detention order by adding: 

"...because (citing applicable sections of the GMP regulations and deviations from them, 

working directly from the FDA 483 but using common, non-statutory language."

3. 21 USC Section 352(a) charge.

- Detention order cites misbranding within the meaning of Section 352(a) in that the 

labeling for the device, which states that the device will cure the common cold, is false or 

misleading.

- Comprehensive statements expand upon the charge in the detention order by adding: "... 

because..."

The same approach should be followed in comprehensive statements where the detention 

order cites misbranding within the meaning of 21 USC Sections 352(f), (j), etc. The 

comprehensive statement simply summarizes the factual basis of division's case. If this 

kind of format is used for a comprehensive statement, the general summary of the 

information which the division will present in support of the detention (21 USC Section 

321(x)(3)) need not consist of anything more than a list of documents (FDA 483, EIR, CR, 

Analyst Worksheet), including affidavits (for example, where the charge is based on the 

absence of an approved PMA or an IDE — see 21 USC Section 351(f)).
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Exhibit 5-17

MODEL HEARING CONFIRMATION LETTER Administrative Detention of Devices

Division Letterhead

Date

Mr. Albert C. Edwards

President

Ace Plastic Company

11124 Railroad Street

Ogallala, Nebraska 69158

Dear Mr. Edwards:

I am confirming the information listed below discussed during our telephone conversation 

of today.

The hearing you requested on the appeal of the administrative detention of your devices 

will be held on at the Kansas City division office, 1009 Cherry Street, Kansas City, 

MO at 9:00 a.m.

The hearing will be a closed hearing because the proceedings constitute an open 

investigatory record. This means that only you, your counsel, witnesses, and employees as 

well as FDA representatives will be allowed to attend.

The regulations on administrative detention 21 CFR 800.55 states that 21 CFR Part 16 will 

be followed in conducting the hearing, however, the regulations make the following 

exceptions to Part 16:

1. 21 CFR 16.22(a), concerning the issuance of a separate notice of opportunity for a 

hearing, is not applicable since the Detention Notice also serves as that notice.

2. 21 CFR 16.22(b), concerning the appeal being sent to the Presiding Officer, is not 

applicable since the regulations require the appeal to be sent to the Division Director of the 

division where the devices are located.

3. 21 CFR 16.24(e), concerning not holding the hearing within two (2) days of the appeal, 

is not applicable because of the short time frames involved. We can hold the hearing within 

two (2) days of your appeal.

4. 21 CFR 16.42(a), concerning those persons who may act as the Presiding Officer, is not 

applicable because I have been designated by regulations as the Presiding and Deciding 

Official.
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I am authorized by 21 CFR 10.19 and 21 CFR 16.60(h) to waive, modify, or suspend any 

provision under 21 CFR Part 16. I am waiving or modifying the following provisions:

1. 21 CFR 16.60(f), which requires the presiding officer to make a recommended decision 

with statements of reasons to the deciding official, is not applicable because I am the 

Deciding Official as well as the Presiding Officer in this instance.

2. 21 CFR 16.95(b)(1) and (2) which state that the Administrative Record of a Regulatory 

Hearing (21 CFR 16.80(a)) is the exclusive record and basis respectively for the decision. 

The decision will not be based on any material that is not part of the administrative record. 

I am modifying 21 CFR 16.95(b)(1) and (2), however, because the decision will be based 

in most cases, on all information presented to me prior to or during the hearing. The 

decision will not be based on the following information or documents if they are not 

received or completed by me within the time period necessary for me to review or 

complete them prior to making a decision as required by the Act or regulation:

a. Information and views I have permitted to be submitted after the hearing, are not 

part of the official record unless the post hearing submissions and information is submitted 

within the time specified by me.

b. Any transcript of the hearing.

c. My Report of the Hearing and any comments on the report.

3. That part of 21 CFR 16.60(b) is waived which provides that all parties may confront and 

conduct reasonable cross-examination of any person (except for the presiding officer and 

counsel for the parties) who makes any statement on the matter at the hearing. 

Reasonable questioning will be allowed instead. Reference congressional intent: House of 

Representatives Report no. 94-853 and 21 CFR 16.5 and 16.60(h).

If feasible, at least one (1) day before the hearing, you are to provide the Division Director 

with written notice of, or a copy of if the Director could not reasonably be expected to 

obtain a copy, any published articles or written information you intend to present or rely 

upon at the hearing as required by 21 CFR 16.24(g).

Any written communication you forward or present to me must be sent by you to all other 

participants to the hearing as required by 21 CFR 16.44(c).

You are requested to provide at the hearing a brief summary of any lengthy documents 

you intend to present at the hearing.

If you have any additional questions on the procedures I will follow at the hearing, you may 

contact me prior to the hearing.

Sincerely yours,
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Albert Smith

Division Director
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Exhibit 5-18

MODEL ORDER 1/

Administrative Detention of Devices

Division Letterhead

Date

Order

Ace Plastic Company

11124 Railroad Street

Ogallala, Nebraska 69158

Dear Sir:

Based on my review of the material (make brief reference to the documents used by the 

presiding officer, (e.g. FDA 483, analyst worksheet, published article, CR, EIR, etc. and 

testimony) presented in the appeal of Detention Order number ________________, I 

hereby order that the Detention Order be confirmed (revoked) because there is 

(insufficient) reason to believe that the devices are adulterated (misbranded) within the 

meaning of Section _____________ of the Federal Food, Drug, and Cosmetic Act in that

_______________________________________________________.

Albert Smith

Division Director

1/ Short Form: To be used when separate written decision/report of the hearing must be 

prepared later, due to short time frame for the order.

2/ Delete "of section ", and "in that " if the detention is revoked.
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EXHIBIT 5-19

MODEL ORDER OF RETENTION, RECALL, AND/OR DESTRUCTION

ORDER OF RETENTION, RECALL, AND/OR DESTRUCTION 

Date Issued: MMM DD, YYYY

Issued To: Name of Responsible Individual

Title

Establishment Name

Address

CITY, ST, ZIP CODE Dear [NAME],

The Food and Drug Administration (FDA) conducted an inspection of your facility at 

[ADDRESS if different than above] on [MM DD, YYYY], covering the manufacture of 

human cell, tissue, and cellular and tissue based products (HCT/Ps) subject to Title 21, 

Code of Federal Regulations, Part 1271 (21 CFR Part 1271). Our review of the information 

and records examined and collected during the inspection show that certain HCT/Ps 

received and distributed by your organization may be in violation of 21 CFR Part 1271, as 

indicated below:

[LIST VIOLATIONS]

- Between [DATE] and [DATE], [QUANTITY/TYPE] HCT/Ps from NNN donors 

were distributed which were repeatedly reactive for HBsAg/HIV by EIA (21 CFR 

1271.85). (Example)

Pursuant to 21 CFR 1271.440, the above referenced HCT/Ps must be:

- Recalled (if distributed), within five (5) working days of receipt of this order, 

under the supervision of an authorized official of the FDA, and/or

- Destroyed by an acceptable method of disposition, within five (5) working days of 

receipt of this order, under the supervision of an authorized official of the FDA, or

- Retained until it is recalled, destroyed, the safety of the HCT/P is confirmed, or 

an agreement is reached with the FDA for its proper disposition under the 

supervision of an authorized official of the FDA.

[NAME OF FIRM], its owners, employees, and agents shall not distribute or dispose of the 

HCT/P in any manner except to recall and destroy it consistent with the provisions of the 

Order. Any other arrangements for ensuring the proper disposition of the HCT/Ps must be 

agreed upon in writing by [NAME OF FIRM] and an authorized official of the FDA. Such 

arrangements may include assurance that the HCT/P has been recovered, processed, 

stored, and distributed in conformance with the attached regulations (21 CFR Part 1271).

All actions taken pursuant to this Order, or otherwise related to the products subject to this 

Order, shall be taken under the supervision of an authorized Official of the FDA.
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Within five (5) working days from the receipt of this Order, the recipient of the written Order 

or prior possessor of such HCT/P may appeal the Order to the Division Director, [NAME], 

Division, Food and Drug Administration, [ADDRESS, CITY, STATE, ZIP CODE] and 

request a hearing on the matter in accordance with 21 CFR Part 16 (copy attached). Such 

manner of appeal is described in 21 CFR 1271.440(e) of the attached regulations. Failure 

to request a hearing within the specified time period constitutes a waiver of the right to a 

hearing.

Please contact [NAME], Compliance Officer, at [TELEPHONE NUMBER], to arrange for 

supervision of the disposition of the products.

[SIGNATURE BLOCK] Division Director

Attachments (2)

21 CFR Part 1271

21 CFR Part 16

cc: Name and Address of any other HCT/P manufacturer or organization with interest 

in/jurisdiction over this HCT/P.

HFM-360

HFM-100

HFC-210

HFC-230

GCF-1
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Exhibit 5-20: Disqualification Proceedings Flowchart
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Exhibit 5-21

Sample NIDPOE

[Date] 

CERTIFIED MAIL - RETURN RECEIPT REQUESTED 

[Clinical Investigator’s Name and Address]

NOTICE OF INITIATION OF DISQUALIFICATION PROCEEDINGS AND OPPORTUNITY 

TO EXPLAIN

Dear [Clinical Investigator’s Name]:

Between [inspection start date] and [inspection ending date], Food and Drug Administration 

(FDA) (hereafter referred to as the “Agency”) investigators conducted an inspection of the 

following clinical study in which you participated: [title of clinical study]. This inspection was 

conducted as part of the FDA's Bioresearch Monitoring Program that includes inspections 

designed to monitor the conduct of research involving investigational products.

[For drugs, biologics, devices] Based on our evaluation of information obtained by the 

Agency, we believe that you have [repeatedly and/or deliberately violated regulations 

governing the proper conduct] [and] [repeated and/or deliberately submitted false 

information in a required report] of clinical studies involving [an investigational new drug] [an 

investigational device] as published under Title 21, Code of Federal Regulations (CFR), Part 

[312, 812] (copy enclosed).

[For new animal drugs] Based on our evaluation of information obtained by the Agency, we 

believe that you have [repeatedly and/or deliberately failed to comply with the conditions of 

the exempting regulations] [and] [repeated and/or deliberately submitted false information in 

a required report], as published under Title 21, Code of Federal Regulations (CFR), Part 

511.1(b) (copy enclosed).

This letter provides you with written notice of the matters complained of and initiates an 

administrative proceeding, described below, to determine whether you should be disqualified 

from eligibility to receive test articles as set forth under 21 CFR [312.70, 812.119, 511.1(c)], 

and disqualified from eligibility to conduct any clinical investigation that supports an 

application for a research or marketing permit for products regulated by FDA including 

drugs, biologics, devices, new animal drugs, food, including dietary supplements, that bear a 

nutrient content claim or a health claim, infant formulas, food and color additives, and 

tobacco products.
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A listing of the violations follows. The applicable provisions of the CFR are cited for each 

violation.

[Insert List of Violations]

This letter is not intended to be an all-inclusive list of deficiencies with your clinical studies of 

investigational [name of investigational product]. It is your responsibility to ensure adherence 

to each requirement of the law and relevant regulations.

On the basis of the above listed violations, FDA asserts that you have [repeatedly and/or 

deliberately failed to comply with the cited regulations] [for new animal drugs: failed to 

comply with the conditions of the exempting regulations] [and] [repeatedly and/or 

deliberately submitted false information] and it proposes that you be disqualified as a clinical 

investigator.

You may reply to the above stated findings, including an explanation of why you should 

remain eligible to receive test articles and not be disqualified as a clinical investigator, in a 

written response or at an informal conference in my office. This procedure is provided for by 

regulation 21 CFR [312.70, 812.119, 511.1(c)].

Within fifteen (15) working days of receipt of this letter, write or call me at [Center contact 

phone number] to arrange a conference time or to indicate your intent to respond in writing. 

Your written response will need to be forwarded within thirty (30) working days of receipt of 

this letter. Your reply should be sent to [Center contact].

Should you request an informal conference, we ask that you provide us with a full and 

complete explanation of the violations listed above. You should bring with you all pertinent 

documents. A representative of your choosing may accompany you. Although the 

conference is informal, a transcript of the conference will be prepared. If you choose to 

proceed in this manner, we plan to hold such a conference within thirty (30) days of your 

request.

At any time during this administrative process, you may enter into a consent agreement with 

FDA regarding your future use of test articles. Such an agreement would terminate this 

disqualification proceeding. Enclosed you will find a proposed agreement between you and 

FDA.

The [center name] (“the Center”) will carefully consider any oral or written response. If your 

explanation is accepted by the Center, the disqualification proceeding will be terminated. If 

your written or oral responses to our allegations are unsatisfactory, or we cannot come to 

terms on a consent agreement, or you do not respond to this notice, you will be offered a 

regulatory hearing before FDA, pursuant to 21 CFR Part 16 (enclosed) and 21 CFR Part 

[312, 812, 511.1]. Before such a hearing, FDA will provide you notice of the matters to be 

considered, including a comprehensive statement of the basis for the decision or action 

taken or proposed, and a general summary of the information that will be presented by FDA 

in support of the decision or action. A presiding officer who has not participated in this matter 
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will conduct the hearing. The Commissioner will determine whether you will remain entitled 

to receive test articles. You should be aware that neither entry into a consent agreement nor 

pursuit of a hearing precludes the possibility of a corollary judicial proceeding or 

administrative remedy concerning these violations.

Sincerely yours,

[Designated Center Signatory + title] Enclosures (2)

[To blind copy electronically, send to the relevant party at firstname.lastname@fda.hhs.gov; 

for hardcopy distribution at the White Oak (WO) campus, include the building and room 

numbers] 

OCC; WO31/WO32

DFOI; ELEM-1029

OGCP; WO32-5129

ORA, Division of Enforcement; WO32

[Originating Center- Center files and distribution]

[Relevant Division Office- Division Personnel, including the Division Director; Director, 

Investigations

Branch; and the Division Investigator(s)] CDER, OSI; WO51

CBER, BIMO group; HFM-664

CVM, BIMO group; HFV-234

CDRH, BIMO group; WO66, BIMO@cdrh.fda.gov

CFSAN, BIMO group; HFS-205
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Exhibit 5-22

Sample Consent Agreement

Agreement with Respect to Use of Investigational Products

The [Center name] (“the Center”) of the United States Food and Drug Administration (FDA) 

and [clinical investigator’s name] hereby agree as follows:

1. [Clinical investigator’s name] conducted investigational clinical studies, including the 

following:

______________________________________________________________________

______________________________________________________________________

2. Between [inspection start date] and [inspection ending date], FDA conducted an 

investigation of the [number or identify] clinical studies performed by [clinical 

investigator’s name]. As a result of the investigation, FDA determined that these studies 

contained sufficiently serious deficiencies to warrant the initiation of proceedings to have 

[clinical investigator’s name] declared ineligible to receive investigational [article(s)], 

pursuant to 21 U.S.C. [appropriate section]. Specifically, FDA concluded that [clinical 

investigator’s name] has:

______________________________________________________________________

______________________________________________________________________

3. By letter dated [date of NIDPOE letter], the Center provided [clinical investigator’s name] 

with written notice pursuant to 21 CFR [312.70, 812.119, 511.1(c)], of the foregoing 

violations and the information which led the Center to believe that [clinical investigator’s 

name] [violated FDA regulations governing the use of investigational [article]] [has 

submitted false information in a required report].

4. In the written notice, the Center also invited [clinical investigator’s name] to attend an 

informal conference to respond to the allegations or to provide a written response to the 

allegations.

5. [Clinical investigator’s name] does not wish to contest the above allegations.

6. Beginning on the date this agreement is executed by the parties, [clinical investigator’s 

name] is not eligible to receive investigational drugs, animal drugs, biologics, devices, or 

food additives, and is not entitled to conduct any further studies, intended or required for 

submission to FDA, of investigational articles regulated by FDA. [Clinical investigator’s 

name] agrees to return to the sponsors of the investigational clinical studies in which [he] 

[she] participated, any and all remaining investigational articles in [his] [her] possession,

custody, or control.

7. [Clinical investigator’s name] waives [his] [her] opportunity to provide a written 

explanation and [his] [her] opportunity to attend an informal conference, and to any 

regulatory hearing pursuant to 21 CFR Part 16 and 21 CFR [312.70, 812.119, 511.1(c)].

______________________________________________________________________
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8. This consent agreement terminates the administrative proceeding in this present matter, 

which included the opportunity for an informal conference or a written explanation and a 

regulatory hearing pursuant to 21 CFR Part 16 and 21 CFR [312.70, 812.119, 511.1(c)].

9. This agreement does not preclude the United States or any other Agency or private entity 

or person from bringing other proceedings relating to the matters underlying this 

agreement, and FDA's acceptance of the terms of this agreement may not serve as a 

defense in any proceedings that the United States or any other Agency or private entity 

or person may initiate against [clinical investigator’s name].

10. [Clinical investigator’s name] acknowledges that double jeopardy would not attach 

should the United States bring any criminal charges against [him] [her] in connection with 

any matter relating to the agreement.

11. By this agreement, [clinical investigator’s name] is disqualified as a clinical investigator. 

Disqualification pursuant to this agreement has the same legal effect as being 

disqualified pursuant to 21 CFR [312.70, 812.119, 511.1(c)] after a Part 16 hearing.

12. FDA is authorized to and will notify the sponsors of the investigational clinical studies in 

which [clinical investigator’s name] has participated as an investigator. FDA also will 

notify the Institutional Review Board (IRB) with authority to oversee clinical studies 

performed by [clinical investigator’s name] that [clinical investigator’s name] has entered 

into this consent agreement. The notifications may contain a statement of the basis for 

[clinical investigator’s name] not being eligible to receive or study investigational articles 

and the subsequent steps the sponsors and IRB should take.

13.FDA may make copies of this agreement available to the sponsors, IRBs and other 

interested parties.

14.With respect to this agreement, [clinical investigator’s name] shall abide by the decisions 

of FDA; these decisions shall be considered the final decisions by FDA in this matter.

FDA’s decisions under this agreement shall be reviewed by any reviewing court, if 

necessary, under the standards set forth in 5 USC 706(2)(A).

15.[Clinical investigator’s name] name will be added to the list of clinical investigators’

entitled “Clinical Investigators- Disqualification Proceedings”, which is available to the 

public on the web pursuant to the Freedom of Information Act (5 USC 552).

Agreed to:

_____________________________ ______________

[Clinical investigator’s name] Date

_____________________________ ______________

[Designated Center signatory + title] Date
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Exhibit 5-23

Sample Notice of Opportunity for Hearing (NOOH)

[Date]

CERTIFIED MAIL- RETURN RECEIPT REQUESTED

[Clinical Investigator’s and/or his/her counsel’s Name & Address]

NOTICE OF OPPORTUNITY FOR HEARING

Dear [Clinical Investigator and/or his/her counsel]:

The [Center name] (“the Center”), Food and Drug Administration (FDA) has information 

indicating that you [repeatedly and/or deliberately violated Federal regulations] [and] 

[repeatedly and/or deliberately submitted false information in a required report] in your 

capacity as an investigator in clinical trials with [an investigational new drug] [investigational 

new animal drug] [an investigational device]. The [violations] [and] [submission of false 

information] provide(s) the basis for withdrawal of your eligibility as a clinical investigator to 

receive [investigational new drugs] [investigational new animal drugs] [investigational 

devices].

Pursuant to section [312.70, 812.119, 511.1(c)] of Title 21, Code of Federal Regulations 

(CFR), the Center informed you, by letter dated [date of NIDPOE letter], of the specific 

matters complained of and offered you an opportunity to respond to them in writing or at an 

informal conference. That same letter gave you the option of entering into a consent 

agreement with the Agency, thereby terminating any administrative proceedings against you.

[State how the investigator responded to this offer whether by not responding, responding in 

writing, or attending an informal conference]. [The Center has concluded that your [written 

explanation] [explanation offered at your informal conference] is unacceptable because it 

fails to adequately address the violations set forth below. [By failing to respond to the letter 

of [date of NIDPOE letter], you waived your opportunity to provide a written response or for 

an informal conference.]

Accordingly, you are being offered an opportunity for a regulatory hearing pursuant to 21 

CFR Part 16 and [312.70, 812.119, 511.1(c)], on the question of whether you are eligible to 

receive [investigational new drugs] [investigational new animal drugs] [investigational 

devices]. You have the right to be advised and represented by counsel at all times. Any 

regulatory hearing on this matter will be governed by the regulations in 21 CFR Part 16 and 

the Agency's guidelines on electronic media coverage of administrative proceedings, 21 

CFR Part 10, Subpart C. Enclosed you will find copies of these regulations.

A listing of the specific violations follows. These are the matters that will be considered at the 

regulatory hearing. Applicable provisions of the CFR are cited for each violation.

[Set out violations in numbered paragraphs. Cite CFR provision for each violation.]
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Your request for a hearing should be made, in writing, within ten (10) working days of receipt 

of this letter and should be directed to [name of DE director], Director, Division of 

Enforcement, ORA, Telephone [DE phone number], Fax [DE fax number]. If no response to 

this letter is received by that time, you will be deemed to have waived any right to a 

regulatory hearing, and a decision in this matter will be made based on the facts available to 

the Agency. No hearing will be held.

A request for a hearing may not rest upon mere allegations or denials but must present 

specific facts showing that there is a genuine and substantial issue of fact that warrants a 

hearing. Pursuant to 21 CFR 16.26, a request for a hearing may be denied, in whole or in 

part, if the Commissioner or his delegate determines that no genuine and substantial issue 

of fact had been raised by the material submitted. A hearing will not be granted on issues of 

policy or law. Written notice of a determination of summary judgment will be provided, 

explaining the reasons for denial of the hearing.

If you wish to respond but do not desire a hearing, you should contact [Name of DE director] 

within the time period specified above and send a written response containing your reply.

The letter should state that you waive your right to a hearing and that you want a decision on 

the matter to be based on your written response and other information available to the 

Agency.

The Agency's offer to enter into a consent agreement attached to the Notice of Initiation of 

Disqualification Proceedings and Opportunity to Explain letter dated [date of NIDPOE letter] 

remains available. Entering into a consent agreement would terminate the administrative 

proceedings, but would not preclude the possibility of a corollary judicial proceeding.

No final decision by FDA has been made at this time on your eligibility to continue to use 

[investigational new drugs] [investigational new animal drugs] [investigational devices]. 

Moreover, there will be no prejudgment of this matter if you decline to enter into a consent 

agreement and decide instead either to request a regulatory hearing or to request that the 

decision be based on information currently available to the Agency.

Please inform [name of DE director] within ten (10) working days of whether you wish to 

request a hearing or to have this matter resolved by consent agreement or information 

available to the Agency.

Sincerely,

[Name]

Associate Commissioner for Regulatory Affairs

Enclosures (3)
Regulatory Procedures Manual October 2019 Chapter 5-Adminsitrative Actions

MAN-00000# Page 167 of 172 Revision ##

[To blind copy electronically, send to the relevant party at firstname.lastname@fda.hhs.gov; 

for hardcopy distribution at the White Oak (WO) campus, include the building and room 

numbers] OCC; WO31/WO32

DFOI; ELEM-1029

OGCP; WO32-5129

ORA, Division of Enforcement; WO32

[Originating Center- Center files and distribution]

[Relevant Division Office- Division Personnel, including the Division Director; Director, 

Investigations Branch; and the Division Investigator(s)]

CDER, OSI; WO51

CBER, BIMO group; HFM-664

CVM, BIMO group; HFV-234

CDRH, BIMO group; WO66, BIMO@cdrh.fda.gov

CFSAN, BIMO group; HFS-205
Regulatory Procedures Manual October 2019 Chapter 5-Adminsitrative Actions

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Exhibit 5-24

MODEL LETTER GRANTING HEARING – Administrative Detention of Drugs

[Division/DE Letterhead]

Date

Mr. John E. Smith

XYZ, Inc.

123 Smith Lane

Anywhere, MS

RE: Administrative Detention Order DO [insert #]

Dear Mr. Smith:

I am confirming the information discussed during our telephone conversation today

regarding the hearing you requested in your appeal of the administrative detention of

[insert description of drug] located at [insert location].

I am granting your request for a hearing and providing additional information about the

hearing. The hearing you requested will be held on [insert date] at [insert time] at the

[insert Division Office, street address, city, state, and Zip Code].

The hearing will be a closed hearing because the proceedings constitute an open

investigatory record (21 CFR 16.60(a)). This means that only you, your counsel,

witnesses, and employees as well as FDA representatives will be allowed to attend.

I am authorized by 21 CFR 10.19 and 21 CFR 16.60(h) to waive, modify, or suspend any

provision under 21 CFR part 16. I am modifying 21 CFR 16.60(b), which provides that all

parties may confront and conduct reasonable cross-examination of any person (except for

the presiding officer and counsel for the parties) who makes any statement on the matter

at the hearing. Reasonable questioning will be allowed instead.

If feasible, at least one (1) day before the hearing, you are to provide the Division Director

with written notice of, or a copy of, if the Division Director could not reasonably be

expected to obtain a copy, any published articles or written information that you intend to

present or rely upon at the hearing, as required by 21 CFR 16.24(g). You may provide

this

information by facsimile: [insert number], electronically: [insert e-mail], or courier: [insert

name and address of Division Director].

Any written communication you forward or present to me must be sent by you to all other

participants to the hearing as required by 21 CFR 16.44(c).
Regulatory Procedures Manual October 2019 Chapter 5-Adminsitrative Actions

MAN-00000# Page 169 of 172 Revision ##

You are requested to provide at the hearing a brief summary of any lengthy documents

you intend to present at the hearing.

If you have any additional questions on the procedures I will follow at the hearing, you may

contact me at [insert phone number] prior to the hearing.

Sincerely yours,

[Presiding Officer]
Regulatory Procedures Manual October 2019 Chapter 5-Adminsitrative Actions

MAN-00000# Page 170 of 172 Revision ##

Exhibit 5-25

MODEL LETTER DENYING HEARING – Administrative Detention of Drugs

(Division/OE Letterhead)

Date

Mr. John E. Smith

XYZ, Inc.

123 Smith Lane

Anywhere, USA

RE: Administrative Detention Order DO [insert #]

Dear Mr. Smith:

This is a follow-up to our telephone conversation today regarding the hearing you

requested as part of your appeal of the administrative detention of [insert description of

drug] located at [insert location].

I am denying your request for a hearing because you have not raised a genuine and

substantial issue of fact (21 CFR 16.26(a)). Specifically, [insert reason why no genuine

and substantial issue of fact was raised by the appellant].

Sincerely yours,

Presiding Officer
Regulatory Procedures Manual October 2019 Chapter 5-Adminsitrative Actions

MAN-00000# Page 171 of 172 Revision ##

Exhibit 5-26 

MODEL LETTER – FINAL DECISION ON APPEAL OF ADMINISTRATIVE DETENTION

ORDER – CONFIRMATION

Administrative Detention of Drugs

[Division/OE Letterhead]

Date

Decision on Appeal –Confirmation

Administrative Detention Order DO [insert #]

Mr. John E. Smith

XYZ, Inc.

123 Smith Lane

Anywhere, MS

Dear Mr. Smith:

I am confirming the administrative detention order for [insert description of drug] located

at [insert location] because [insert reason why confirming detention].

[If information that supports the administrative detention is, in whole or in part,

CLASSIFIED information, insert the following:]

My decision is based [in whole or in part] on classified information.

[If information that supports the administrative detention is not CLASSIFIED information,

insert the following:]

My decision is based on information you submitted in your appeal [and information

presented by all parties at the hearing on the appeal].

The administrative detention is effective until [insert date], unless FDA issues a detention

termination notice prior to that date. It is a prohibited act under section 301(r) of the

Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 331(r), to move a detained drug in 

violation of a detention order under section 304(g).

Sincerely yours,

[Presiding Officer]
Regulatory Procedures Manual October 2019 Chapter 5-Adminsitrative Actions

MAN-00000# Page 172 of 172 Revision ##

Exhibit 5-27 

MODEL LETTER – FINAL DECISION ON APPEAL OF ADMINISTRATIVE DETENTION

ORDER – REVOCATION

Administrative Detention of Drugs [Division/OE 

Letterhead]

Date

Decision on Appeal – Revocation Administrative

Detention Order DO [insert #]

Mr. John E. Smith XYZ, Inc.

123 Smith Lane

Anywhere, MS

Dear Mr. Smith:

I am revoking the administrative detention order for [insert description of drug] located at

[insert location] because [insert why the order is being revoked]. The administrative

detention is terminated as of this date and the drug is released. You may remove the labels

and tags relating to the detention and return the tags to the Division Director.

[If information utilized to support the administrative detention is, in whole or in part,

CLASSIFIED information, insert the following:]

My decision is based [in whole or in part] on classified information.

[If information utilized to support the administrative detention is not CLASSIFIED information,

insert the following:]

My decision is based on information you submitted in your appeal [and at the hearing on 

the appeal]. Thus, FDA no longer has reason to believe the drug is adulterated or

misbranded.

Sincerely,

[Presiding Officer]