FOOD AND DRUG ADMINISTRATION 

OFFICE OF REGULATORY AFFAIRS 

Document Number: 

FMD.086 

Revision #: 07 

Revised:12/14/2022 

FMD 86: Establishment Inspection Report Conclusions and Decisions Page 1 of 22 

Sections in This Document 

Purpose........................................................................................................................................ 1 

Scope ........................................................................................................................................... 2 

Responsibility ............................................................................................................................... 3 

Background .................................................................................................................................. 4 

References ................................................................................................................................... 6 

Procedure..................................................................................................................................... 6 

6.1. ORA Conducted Surveillance Inspections ................................................................... 6 

6.2. ORA Conducted Compliance Follow-Up...................................................................... 9 

6.3. ORA Conducted for Cause Inspections (ORA or Center Initiated) ............................. 11 

6.4. ORA Conducted Pre-Approval Inspections................................................................ 11 

6.5. Inspections Conducted Under State Contract............................................................ 11 

6.5.1. Classification of non-violative state contract inspection report ..................... 12 

6.5.2. Classification of violative state contract inspection reports........................... 12 

6.5.3. Classification of state contract inspection report where state action is indicated 

.................................................................................................................... 13 

6.6. Referral to Office of Criminal Investigations (OCI) ..................................................... 14 

6.7. Monitoring Inspection Report Conclusions and Decisions ......................................... 14 

6.8. Instructions for Washouts .......................................................................................... 14 

Records ...................................................................................................................................... 17 

Supporting Documents ............................................................................................................... 17 

Document History ....................................................................................................................... 18 

Change History........................................................................................................................... 18 

Attachments................................................................................................................................ 19 

Attachment A - Advisory Actions.......................................................................................... 20 

Attachment B - Administrative and Judicial Actions.............................................................. 21 

Attachment C - Other Procedures........................................................................................ 22 

Purpose 

This Field Management Directive (FMD) provides definitions, responsibilities, 

and procedures for assigning inspection conclusions, Program Division 

decisions, and the final inspection classification to an Establishment Inspection 

Report (EIR) within established timeframes. 

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FOOD AND DRUG ADMINISTRATION 

OFFICE OF REGULATORY AFFAIRS 

Document Number: 

FMD.086 

Revision #: 07 

Revised:12/14/2022 

FMD 86: Establishment Inspection Report Conclusions and Decisions Page 2 of 22 

Scope 

The classification process, which involves endorsing an inspection and 

entering a firm’s final profile status, must be accurate, timely, and uniform 

since the compliance status of EIRs has broad ramifications and impacts 

directly on critical public health issues. The procedures outlined in this FMD 

are designed to bring greater uniformity in decisions and conclusions in 

conjunction with FDA databases (the Field Accomplishments Compliance 

Tracking System (FACTS), Electronic State Access to FACTS (eSAF), 

eNSpect, Compliance Management Services (CMS), etc.). [Note: Current 

business practice has mostly transitioned to using eNSpect for inspectional 

operations; however, FACTS may still be used on a limited basis for certain 

compliance operations, as well as inspection operations. Therefore, all 

systems are recognized and referenced in this FMD. Furthermore, FDA 

databases may continue to reference the former term “District Decision;” 

however, in this document, this will be referred to as the “Program Division 

Decision.”] 

The procedures in this FMD apply to both domestic and foreign inspections, 

including state contract inspections. Except for instances where Program 

specific procedures indicate that the relevant product center or headquarters’ 

Division is responsible for final classification, the final classification of the 

inspection is made by the ORA Program Office. For foreign inspections, the 

reviewing center office may serve in (or as) the Compliance Branch role with 

the responsibilities described herein. For Produce Safety Rule inspections, the 

reviewing center office serves in (or as) the Compliance Branch role with the 

responsibilities described herein. Centers may follow their respective 

procedures in which they are responsible for final classification. FMDs are the 

primary vehicle for distributing procedural information on the management of 

ORA field activities and is intended as internal instructions to field managers. 

This document does not currently include determinations of inspection 

conclusions and final inspection classifications for Interstate Travel Program 

(ITP) inspections. 

Violations of state law or regulations not actionable under current FDA policy 

are not used to support No Action Indicated (NAI), Voluntary Action Indicated 

(VAI), or Official Action Indicated (OAI) classifications. These violations should 

be pursued under the state programs and the inspection should be classified 

as Referred to State (RTS). Please see the procedures below related to RTS 

classified EIRs. 

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FOOD AND DRUG ADMINISTRATION 

OFFICE OF REGULATORY AFFAIRS 

Document Number: 

FMD.086 

Revision #: 07 

Revised:12/14/2022 

FMD 86: Establishment Inspection Report Conclusions and Decisions Page 3 of 22 

If a Program or Office enters into an agreement with a Center, such as a 

Concept of Operations (CONOPS), the agreement’s timelines and specifics for 

which office will enter final classification and profiles should be followed. All 

other requirements of this FMD will remain in effect. 

Responsibility 

A. Program Division 

1. Program Division Director 

a. Ensures activities are carried out in accordance with this directive 

by the responsible individuals under his/her authority including, 

but not limited to, the Investigations Branch, State Liaison, and 

Compliance Branch. 

B. Investigations Branch (IB) 

1. Director, Investigations Branch (DIB) 

a. Ensures appropriate communication with Compliance Branch, 

when appropriate, when IB makes inspection classification 

decisions. 

2. Supervisory Consumer Safety Officer (SCSO): 

a. Reviews the EIR and evidence collected by FDA Consumer 

Safety Officers (CSO) to determine and enter the Inspection 

Conclusion, Program Division Decision, and where applicable, 

final classifications and Profiles, based on relevant policy and 

procedure (see Section 6 below). 

b. Recommend to Compliance Branch for appropriate action when 

necessary. 

3. Consumer Safety Officer (CSO) 

a. Completes EIR within required timeframe for the specific 

classification. 

C. Compliance Branch (CB) 

1. Director, Compliance Branch (DCB) 

a. Ensures appropriate communication with IB, Center and State 

Liaisons when making final classification decisions. 

b. Reviews and assigns inspections referred to Compliance Branch. 

2. Compliance Officer (CO) 

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FOOD AND DRUG ADMINISTRATION 

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Document Number: 

FMD.086 

Revision #: 07 

Revised:12/14/2022 

FMD 86: Establishment Inspection Report Conclusions and Decisions Page 4 of 22 

a. Reviews the CMS Work Activity for inspections assigned to them 

by their DCB or designee. After assessing the recommended IB 

decision, takes appropriate action as necessary. 

b. Enters the appropriate final profile status in the appropriate FDA 

database (e.g. eNSpect, CMS, etc.), if applicable, within required 

timeframe except in cases where the reviewing Center is 

responsible for entering the final profile. 

c. Enters the final Program Division Decision in the District Decision 

field for each Program Assignment Code (PAC), Establishment 

Type, and Process Code combination in the appropriate FDA 

database (e.g. eNSpect, CMS, etc.) for the cases noted above 

within the required timeframe, except in cases where the 

reviewing Center is responsible for entering the final Program 

Division Decision. 

d. Initiates further activities to evaluate the evidence, e.g. follow-up 

assignments, reference searches, consultations, regulatory 

meetings, etc., to arrive at the appropriate final decision (See 

RPM Chapter 10-3 for further discussion and uses of Regulatory 

Meetings.) 

D. State Liaison 

1. Reviews an EIR prepared by a state inspector and evidence 

collected to determine the Inspection Conclusion, Program Division 

Decision and where applicable Profiles, based on relevant policy 

and procedure, and accept the inspectional information from eSAF 

where applicable. Refers to ORA State Contract Inspection Process 

and state contract inspection’s Statement of Work (SOW) for 

procedures related to reviewing state contract inspection reports. 

2. In consultation with IB and CB, recommends compliance action 

when necessary. 

3. Provides copies of this FMD and any other pertinent guidelines, as 

needed, to the State officials responsible for submitting EIRs to FDA 

and instructs them in the use of these criteria to assure assignment 

of uniform classifications to state inspections performed under FDA 

contracts or agreements. 

Background 

ORA conducts inspections of establishments that manufacture (including 

compounding), process, pack, or hold FDA-regulated products, before 

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FOOD AND DRUG ADMINISTRATION 

OFFICE OF REGULATORY AFFAIRS 

Document Number: 

FMD.086 

Revision #: 07 

Revised:12/14/2022 

FMD 86: Establishment Inspection Report Conclusions and Decisions Page 5 of 22 

approving products and/or after products are on the market, to determine the 

establishment’s compliance with laws administered by FDA. 

ORA provides initial classification of the inspection based on the observations 

noted during the inspection, the investigator’s report, and ORA Program Office 

supervisory personnel review. An initial inspection classification reflects the 

compliance status of the establishment at the time of the inspection, based on 

the observations documented, and endorsed by a supervisory consumer 

safety officer. The compliance status of the inspection, both foreign and 

domestic, is reported as Official Action Indicated (OAI), Voluntary Action 

Indicated (VAI), No Action Indicated (NAI), or Referred to State (RTS) (e.g., 

inspection classification). The initial classification will reflect the “Inspection 

Conclusion,” “Program Division Decision,” and the recommended advisory, 

administrative or judicial action, if applicable. 

Final classifications (submission, supervisory endorsement, and Program 

Division Decision) of EIRs should be completed in accordance with the current 

regulatory action time frames for the anticipated regulatory action, 

commensurate with the classification. Refer to the Statement of Work (SOW) 

for timeframe requirements associated with inspections conducted pursuant to 

a state contract. Please see the Regulatory Procedures Manual for 

timeframes associated with administrative, advisory and judicial actions. 

All endorsements with Program Division Decisions classified as Referred to 

State (RTS), VAI or OAI must (1) cite or be associated with a violation(s) of a 

specific law, regulation, or administrative requirement, (2) identify the specific 

action being recommended, and (3) be supported by documented evidence as 

follows: 

• FDA’s jurisdiction and interstate commerce (unless the classification is 

RTS and FDA cannot or will not take action), and/or 

• A summary of objectionable conditions listed on the Inspectional 

Observations Form FDA 483, and Produce Farm Inspection 

Observations Form FDA 4056 in the EIR, and/or related documents 

which are cited by the Program Office to support a specific regulatory 

(advisory, administrative, or judicial) recommendation or other follow-up. 

Investigations Branch and State Liaisons inform CB whenever objectionable 

conditions are observed that may warrant a regulatory action or follow-up 

communication. IB, State Liaisons and CB will collaborate to ensure that each 

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FOOD AND DRUG ADMINISTRATION 

OFFICE OF REGULATORY AFFAIRS 

Document Number: 

FMD.086 

Revision #: 07 

Revised:12/14/2022 

FMD 86: Establishment Inspection Report Conclusions and Decisions Page 6 of 22 

EIR and the subsequent Program Division Decision, Final Decision, 

recommendations, and final profile status are accurate, timely, uniform, and 

adequately documented. 

References 

A. Investigations Operations Manual (IOM) (Chapter 5) 

B. Regulatory Procedures Manual (RPM) 

C. Compliance Program Guidance Manual (CPGM) 

D. Compliance Policy Guide (CPG) 

E. Guidance for Industry (GFI) 

F. Management of ORA State Contract Inspection Process (SOP-000115) 

G. FMD-50 State Communication 

H. State Contract inspection’s Statement of Work (SOW) 

Procedure 

6.1. ORA Conducted Surveillance Inspections 

A. The EIR should be written and endorsed within a timeframe 

commensurate with the current regulatory action time frames for the 

anticipated regulatory action, but generally not to exceed 30 working 

days when no further action is expected from the “Close Date” of the 

inspection if the inspection will be classified NAI or VAI, unless specific 

program policy and/or CONOPS dictates otherwise. For OAI 

classification, For-Cause Assignments and/or ORA Compliance Followup Assignments, see the Regulatory Procedures Manual and/or 

program specific CONOPS for timeframes associated with 

administrative, advisory and judicial actions. 

B. SCSO reviews the EIR and supporting evidence and determines if any 

objectionable conditions exist. 

C. If objectionable conditions exist and IB is recommending regulatory 

action see section F. (NOTE: IB should consult with CB as soon as 

possible if an advisory, administrative, or judicial action is being 

considered. IB should also consult with CB if a recall activity is in 

progress or being considered.) 

D. NAI Classification 

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FOOD AND DRUG ADMINISTRATION 

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Document Number: 

FMD.086 

Revision #: 07 

Revised:12/14/2022 

FMD 86: Establishment Inspection Report Conclusions and Decisions Page 7 of 22 

1. If no objectionable conditions or practices were found during the 

surveillance inspection, the SCSO enters an Inspection Conclusion 

and final Program Division Decision of No Action Indicated (NAI), 

checks the Final Decision block for each PAC, Establishment Type, 

and Process Code combination, and finalizes profiles, if applicable, 

in eNSpect, unless the Program requires the Center or Compliance 

(for example: a for-cause, compliance follow-up) to review and 

finalize. 

E. VAI Classification with no recommended action or CB referral 

1. If objectionable conditions or practices were found during 

surveillance inspections, and the Division is not prepared to 

recommend an advisory, administrative or judicial action, the SCSO 

enters the Inspection Conclusion of Correction Indicated (CI), a final 

Program Division Decision of Voluntary Action Indicated (VAI), 

checks the Final Decision block for each PAC, Establishment Type, 

and Process code combination, and finalizes profiles, if applicable, 

in eNSpect unless the Program requires the Center or Compliance 

(for example: a for-cause, or compliance follow-up) to review and 

finalize. 

F. Inspections referred to CB 

1. After communication with CB, if IB concludes that valid and 

documented objectionable conditions or practices warrant 

consideration for advisory, administrative, or judicial action, the 

SCSO enters in eNSpect the Inspection Conclusion of Correction 

Indicated (CI) for a Program Division Decision that is recommended 

as VAI or Official Action Indicated (OAI). 

a. If applicable, the CSO or SCSO enters the initial profile status for 

the firm. 

b. The SCSO does not enter a final decision in eNSpect for any 

PAC associated with the inspection. 

c. The SCSO includes in the EIR endorsement a summary of 

inspection findings and a recommended action. 

d. IB refers the case to CB. Refer to IOM Chapter 5.11 Reporting, 

Exhibit 5-14.1 and 5-14.3.10 for violative inspections. 

2. CB reviews the evidence collected to support the recommended 

classification and action. CB consults with IB and Center 

Compliance Officers as necessary and follows procedures for case 

processing contained in the Regulatory Procedures Manual, 

Program procedures and, if applicable CONOPS. 

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Document Number: 

FMD.086 

Revision #: 07 

Revised:12/14/2022 

FMD 86: Establishment Inspection Report Conclusions and Decisions Page 8 of 22 

a. For OAI compliance cases that require Center review, the CO 

should enter an OAI classification decision to reflect the ORA 

Compliance Branch Review. For this circumstance, the OAI 

classification entered by the CO should NOT be marked as the 

final Program Division decision. 

b. Unless roles and responsibilities are specified in a written 

agreement between ORA and the Center (Example: CONOPS), 

the ORA Compliance Officer enters the final Program Division 

Decision and checks the Final Decision block for each PAC, 

Establishment Type, and Process code combination, and if 

applicable, finalizes profiles in the appropriate FDA database 

(e.g. eNSpect, CMS,etc.) within 5 working days of an action 

being taken, or a decision has been made not to pursue an 

action. The ORA CO enters the following: 

i. If the final action taken is a Warning Letter, the Final Decision 

must be OAI. 

ii. If the final action taken is an Untitled Letter, the Final Decision 

must be VAI. 

iii. If the action taken is a Regulatory Meeting, where the 

previous inspection was classified OAI and a Warning Letter, 

administrative, or judicial action was taken, the Final Decision 

may be OAI. 

iv. If the action taken is a Regulatory Meeting, where the 

previous inspection was not classified OAI, the Final Decision 

should be VAI unless the Center or the Program determines 

the inspection is OAI as documented in the CMS case (e.g. in 

a decision memo or a CMS “Activity Note”). (See RPM 

Chapter 10-3 for appropriate uses of Regulatory Meetings.) 

c. Within 5 working days of an action being taken or a decision has 

been made not to pursue an action (NOTE: This decision should 

be documented) the division compliance officer enters the final 

Program Division decision, checks the Final Decision block for 

each PAC, Establishment Type, and product code, and if 

applicable, finalizes profiles in the appropriate FDA database 

(e.g. eNSpect, CMS, etc.) 

G. Referred To State (RTS) Classification 

1. If objectionable conditions or practices are present, but the Agency 

either does not have jurisdiction over the apparent violation or it is 

determined that state action is the most efficient method of obtaining 

the establishment’s compliance with applicable federal or state laws, 

regulations or administrative requirements, IB may endorse in 

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FOOD AND DRUG ADMINISTRATION 

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Document Number: 

FMD.086 

Revision #: 07 

Revised:12/14/2022 

FMD 86: Establishment Inspection Report Conclusions and Decisions Page 9 of 22 

eNSpect a Program Division Decision of Referred to State (RTS) for 

all applicable PAC, Establishment Type, and Process code 

combinations, and notify Compliance Branch of the 

recommendation. Compliance Branch must be informed prior to 

contacting the State. 

2. The Program Division Decision of RTS should not be used for 

inspections where valid and documented objectionable conditions or 

practices warrant consideration for regulatory actions under the 

Agency’s jurisdiction. In these cases, an inspection is viewed as 

OAI, and the IB must enter an Inspection Conclusion of Correction 

Indicated (CI) and a recommendation of OAI as the Program 

Division Decision and follow the steps for OAI inspection 

classifications per section 6.1.F. 

3. The Division maintains close communication with their state partner 

to monitor the action and follow-up inspections, to verify the 

violations were corrected, and/or to ensure appropriate regulatory 

follow up action is taken when appropriate. These follow-up actions 

must be recorded and tracked in CMS under the appropriate 

Referred to State work activity. 

4. If CB concurs with the IB Referred to State recommendation, CB or 

State Liaison prepares the memorandum to the State and creates 

and enters the referral action in CMS under the Work Activity 

category of “District - Referred to State.” CB or State Liaison 

monitors the State’s response and uploads corresponding 

documentation in CMS under the appropriate tabs or sections. 

5. If the final Program Division Decision is different from what was 

recommended, CB or State Liaison changes the Division Decision to 

reflect the appropriate Final Decision in eNSpect. 

6.2. ORA Conducted Compliance Follow-Up 

A. Background: 

An OAI classification indicates that an establishment failed to meet 

either regulatory or administrative requirements and may pose a hazard 

to public health. It also may delay an establishment seeking 

government contracts or approvals. Therefore, an appropriate and 

timely follow-up inspection is encouraged and usually the standard to 

ensure compliance and corrections to violations at an establishment 

where the most recent inspection was classified as OAI. ORA’s goal is 

for these follow-up inspections to be conducted at domestic 

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Document Number: 

FMD.086 

Revision #: 07 

Revised:12/14/2022 

FMD 86: Establishment Inspection Report Conclusions and Decisions Page 10 of 22 

establishments within six months after an OAI classification has been 

finalized and any actions taken. 

B. Assignment Creation Timeframes: 

1. CB will issue to IB a Compliance Follow-up Assignment. Further CB 

will work with IB and/or the Center (if applicable) to schedule a 

follow-up inspection to normally be conducted within six months after 

an OAI classification has been finalized and any actions taken for 

domestic inspections. Exceptions include: 

2. A domestic follow-up inspection may be conducted in less than six 

months after an action is taken as the result of an OAI classification, 

such as when a significant hazard to health exists and/or when the 

Agency may be contemplating an enforcement action. 

3. A domestic follow-up inspection may be conducted greater than six 

months after an action is taken as the result of an OAI classification, 

such as when the firm is actively engaged with the Division 

regarding corrective actions requiring a greater length of time to 

implement or when there are limited resources or there are higher 

priority assignments. If this occurs, the Compliance Officer 

documents the reason in CMS. For foreign establishments with an 

OAI classification, the reviewing Center will determine if a reinspection is needed and work with ORA to schedule the reinspection. 

C. Completion of Follow Up Inspection: 

1. The EIR should be written and endorsed within 10 working days 

from the “Close Date” of the inspection if IB is recommending the 

inspection be classified NAI or VAI unless program specific policy 

and/or CONOPS dictate otherwise. For OAI classification, see the 

Regulatory Procedures Manual for timeframes associated with 

administrative, advisory and judicial actions. NOTE: If shorter 

timeframes are identified in the assignment, follow these timeframes. 

2. SCSO reviews the EIR and determines if any objectionable 

conditions exist. Further IB review may occur. IB may also consult 

with CB (See 6.1.C). 

3. The SCSO endorses the EIR and enters in eNSpect the initial 

Inspection Conclusion and recommended Program Division Decision 

for all PACs for each Establishment Type, and Process Code 

combination, and if applicable, enters the initial profile, in eNSpect. 

For OAI classification, follow procedure in 6.1.F. For RTS 

classification, follow procedure in 6.1.G. 

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FOOD AND DRUG ADMINISTRATION 

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Document Number: 

FMD.086 

Revision #: 07 

Revised:12/14/2022 

FMD 86: Establishment Inspection Report Conclusions and Decisions Page 11 of 22 

4. For Compliance Follow-up, the Compliance Officer enters the final 

Program Division Decision and checks the Final Decision block for 

all PACs for each Establishment Type and Process Code 

combination, and if applicable finalizes the profiles, in the 

appropriate FDA database, such as (e.g. eNSpect, CMS, etc.) 

within 10 working days of concurring with the IB endorsement for 

NAI or VAI inspections. For OAI inspections, CB follows procedure 

in 6.1.F. 

6.3. ORA Conducted for Cause Inspections (ORA or Center Initiated) 

A. If the inspection is classified NAI or VAI follow procedures under 6.1.D 

or 6.1.E, unless program specific policy and/or CONOPS dictate 

otherwise. If the inspection is classified as OAI, follow procedures 

under section 6.1.F. If the inspection is classified RTS, follow procedure 

in 6.1.G. 

6.4. ORA Conducted Pre-Approval Inspections 

A. The timeframes above should be adhered to for NAI, VAI and OAI 

classifications unless program specific policy and/or CONOPS dictates 

otherwise. Follow program specific requirements for determining if the 

Program or the Center finalizes the Program Division Decision in the 

appropriate FDA database (e.g. eNSpect, CMS, etc.). 

6.5. Inspections Conducted Under State Contract 

A. Upon completion of a state inspection conducted under contract, states 

classify inspections in eSAF. Classifications provided for states in 

eSAF vary from those available for FDA within FACTS. The following 

chart compares how the available state eSAF codes transfer over once 

the inspection appears in FACTS. There are two codes in eSAF which 

appear in FACTS as NAI, two eSAF codes which translate to VAI in 

FACTS, one eSAF code that transfers over as OAI in FACTS and one 

other code in eSAF which transfers over into FACTS as RTS. 

eSAF Classification eSAF 

Code 

Transfer 

Code 

FACTS 

Code FACTS Classification 

No action indicated NAI N NAI No Action Indicated (NAI) 

No action/follow-up inspection NFI N NAI No Action Indicated (NAI) 

Voluntary action indicated VAI E VAI Voluntary Action Indicated (VAI) 

Violation/follow-up inspection VFI E VAI Voluntary Action Indicated (VAI) 

Action referred to FDA RAI A OAI Official Action Indicated (OAI) 

State/Title action indicated SAI I RTS Referred to State (RTS) 

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Document Number: 

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FMD 86: Establishment Inspection Report Conclusions and Decisions Page 12 of 22 

6.5.1. Classification of non-violative state contract inspection report 

A. After review of a state contract inspection report, if the State Liaison 

concludes that no objectionable conditions or practices were found 

during the inspection, or the objectionable conditions found do not 

justify further action, then the State Liaison must accept or endorse the 

state designated NAI or NFI (No action/follow-up action) inspection 

classification in the eSAF system. Note that the inspection classification 

codes in eSAF of NAI or NFI are equivalent to the NAI inspection 

classification in FACTS. 

B. For medical device state contract inspections, the Office of Medical 

Device and Radiological Health Operations (OMDRHO) Supervisor 

reviews the contract inspection report to verify if the classification is 

correct. This information is shared with the State Liaison who will accept 

the code in eSAF. 

C. If objectionable conditions and practices were observed, but the 

Division is not prepared to take or recommend any regulatory action, or 

the objectionable conditions found do not justify further action, then the 

State Liaison should accept or endorse the state designated VAI or VFI 

(Violation/follow-up inspection) inspection classification in eSAF. Note 

that the inspection classification codes in eSAF of VAI or VFI are 

equivalent to the VAI inspection classification in FACTS. 

1. Medical device state contract inspections that find significant actions 

are followed-up by the state, not OMDRHO. 

D. The State Liaison is responsible for approving or endorsing the NAI, 

NFI, VAI or VFI inspection classification or inspection package in eSAF 

as soon as possible, but no later than 15 working days after completing 

the review of the inspection report and/or package. 

6.5.2. Classification of violative state contract inspection reports 

A. Classification of state conducted inspections should follow the same 

procedures as for FDA conducted inspections. The following 

procedures should be followed when the division is classifying 

potentially violative inspections from a state inspection. Also, consult 

the Regulatory Procedures Manual for procedures on using state data 

to support FDA action. 

B. If the State Liaison concludes that valid and documented objectionable 

conditions or practices warrant consideration for advisory, 

administrative, or judicial action, and it is determined that further action 

or follow-up by FDA is necessary, then the State Liaison must accept or 

endorse the state-designated RAI inspection classification in eSAF. The 

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Document Number: 

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Revision #: 07 

Revised:12/14/2022 

FMD 86: Establishment Inspection Report Conclusions and Decisions Page 13 of 22 

RAI code in eSAF is equivalent to the OAI inspection classification in 

FACTS. In these instances, the division should not use the RTS 

designation. 

C. The State Liaison includes in the EIR endorsement an evaluation of 

inspection findings and a recommended action and informs CB of the 

recommended action. The State Liaison creates a Division – 

Inspections/Consults work activity in CMS which sends a notification to 

CB in CMS. When FDA takes the action on a state contract inspection, 

IB or State Liaison and CB must follow normal procedures for tracking, 

monitoring and documenting actions and outcomes per procedure 6.1.F 

above. 

D. Compliance Branch reviews the evidence collected to support the 

recommended OAI classification. If appropriate, CB converts the Work 

Activity in CMS to a compliance case. Compliance Branch consults 

with the State Liaison and Center Compliance Officers as necessary 

and follows procedures for case processing contained in the Regulatory 

Procedures Manual. 

E. The Compliance Officer enters the final Program Division Decision and 

checks the Final Decision block for all PACs for each Establishment 

Type and Process Code combination, and if applicable, finalizes profiles 

in FACTS within 5 working days of an action being taken or a decision 

has been made not to pursue an action is made. 

F. For OAI inspection classifications resulting in cases where Center 

concurrence is required, and the Center Compliance Officer changes 

the action and/or classification to VAI, CB enters the final Program 

Division Decision, documents the reason for the change in the Remarks 

section, checks the Final Decision block for all PACs for each process 

code, and if applicable, finalizes profiles in FACTS within 5 working 

days of an action being taken or a decision has been made not to 

pursue an action. 

6.5.3. Classification of state contract inspection report where state 

action is indicated 

A. After review of the state contract inspection report, if objectionable 

conditions or practices are present, but the Agency either does not have 

jurisdiction over the apparent violation in question or it is determined 

that state action is the most efficient method of obtaining the 

establishment’s compliance with applicable federal or state laws, 

regulations or administrative requirements, the State Liaison may 

recommend the State consider some action and notify Compliance 

Branch of the recommendation. The State Liaison must accept or 

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Document Number: 

FMD.086 

Revision #: 07 

Revised:12/14/2022 

FMD 86: Establishment Inspection Report Conclusions and Decisions Page 14 of 22 

endorse the state-designated state contract inspection in eSAF as SAI. 

Note that the inspection classification code of SAI in eSAF is equivalent 

to the RTS inspection classification in FACTS. The State Liaison 

notifies Compliance Branch of the State’s action and activities. 

Compliance Branch must be informed prior to contacting the State. 

1. The division must maintain close communication with their state 

partner to track and monitor the action taken and completion of 

follow-up inspections and to verify that the violations were corrected 

or that appropriate regulatory follow up is taken. These follow-up 

actions must be recorded and tracked in CMS under the Program 

Division – Referred to State work activity. The State Liaison is 

responsible for creating the work activity in CMS and monitoring the 

State’s follow-up actions or activities. All associated documents 

must be uploaded to the record under the appropriate tabs or 

sections. 

6.6. Referral to Office of Criminal Investigations (OCI) 

A. Whenever an EIR is referred to OCI for further investigative follow-up or 

as part of an OCI case, the report should be classified as OAI. Please 

see IOM 5.2.2.5 for information related to when evidence related to 

potential criminal activity is found during a regulatory inspection. 

6.7. Monitoring Inspection Report Conclusions and Decisions 

A. The Program Division Director, or designee, evaluates the data on the 

ORA Program Accomplishment Dashboard to monitor the number of 

inspections without a final decision on a periodic basis. 

B. The Program Division Director, or designee, reconciles any inspections 

without a final decision that are outside the timeframes in this FMD and 

ensures corrective actions are taken to prevent recurrence. 

6.8. Instructions for Washouts 

A. Whenever an establishment assigned to be inspected is determined to 

be Out of Business (OOB), or no inspection was made since the firm is 

not FDA regulated, seasonal operations only, or inactive, no “Inspection 

Conclusion” and “Program Division Decision” or other inspection data 

should be entered for this assignment. 

1. In this case, an inspection operation should be converted to an 

investigation operation (OP13 if domestic and OP15 if foreign) and 

reported as a “washout”. eNSpect User Guide contains instructions 

to convert the inspection operations to an investigation operation 

and “set to washout” for one of seven different reasons, including: 

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FOOD AND DRUG ADMINISTRATION 

OFFICE OF REGULATORY AFFAIRS 

Document Number: 

FMD.086 

Revision #: 07 

Revised:12/14/2022 

FMD 86: Establishment Inspection Report Conclusions and Decisions Page 15 of 22 

inactive, not official establishment inventory, out of business, firms 

don’t meet assignment criteria, not FDA obligation, pre-production, 

and seasonal. 

7. Glossary/Definitions 

A. The Inspection Conclusion: 

1. Indicates IB management’s (or State Liaison's) evaluation of the 

significance of objectionable conditions and/or practices found 

during the inspection. NOTE: If an inspection covers more than one 

PAC and product/process, there must be an Inspection Conclusion 

recorded for each PAC and product code combination. 

2. Inspection Conclusion definitions are listed as follows: 

Inspection Conclusion Definition 

No Action Indicated (NAI) No objectionable conditions or practices were 

found during the inspection (or the significance of 

the documented objectionable conditions found 

does not justify further FDA action). 

Correction Indicated (CI) Objectionable conditions and practices were found 

during the inspection, for which the establishment 

failed to meet either regulatory or administrative 

requirements. A CI conclusion should be made 

only if an FDA 483, FDA 4056, or state equivalent, 

has been issued unless the only significant 

observations are non-reportable as specified by 

IOM 5.2.3.3. Correction may be achieved through 

the firm’s voluntary action or FDA action. 

B. Program Division Decisions 

1. The Program Division Decision represents the action that the 

Division will take or recommend after considering the findings of the 

inspection, any events that occurred following the findings, and 

Agency policy. Investigation and Compliance personnel are 

responsible for entering the Program Division Decision for EIRs as 

outlined in the Procedure section of this FMD. The Final Program 

Division Decision represents the final classification of the inspection 

and is completed after an action being taken or a decision has been 

made not to pursue an action. Each PAC will require a Final 

Division Decision and the worse-case PAC is the overall final 

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FOOD AND DRUG ADMINISTRATION 

OFFICE OF REGULATORY AFFAIRS 

Document Number: 

FMD.086 

Revision #: 07 

Revised:12/14/2022 

FMD 86: Establishment Inspection Report Conclusions and Decisions Page 16 of 22 

classification for the inspection. For example, an inspection may 

have several PACs, some of which have a Final Division Decision of 

NAI, VAI, and OAI (see definitions below). In this case, the final 

classification for the inspection would be OAI. In FDA databases, 

this may be referred to by the former term, “District Decision.” 

The following Division Decisions will be used as applicable: 

Division Decision Definition 

No Action Indicated 

(NAI) 

No objectionable conditions or practices were found 

during the inspection (or the significance of the 

documented objectionable conditions found does not 

justify further action). 

Voluntary Action Objectionable conditions were found and documented 

Indicated (VAI) but the Division and/or Center is not prepared to take or 

recommend any of the following regulatory actions 

(warning letter, administrative, or judicial) since the 

objectionable conditions do not meet the threshold for 

these actions. The division may use an Untitled Letter, 

Response Letter, or Regulatory Meeting or other 

communication with responsible individuals to inform the 

establishment of findings that should be corrected. The 

division may request a written response from the 

establishment, but this is not necessary. Any corrective 

action is left to the establishment to take voluntarily. A 

VAI classification should be made only if an FDA 483, 

FDA 4056. or state equivalent, has been issued unless 

the only significant observations are non-reportable as 

specified by IOM 5.2.3.3. A VAI classification can be 

made only if the Inspection Conclusion is CI. 

Official Action Objectionable conditions were found and regulatory 

Indicated (OAI) (advisory, administrative, or judicial) action should be 

recommended. NOTE: There are specific criteria 

described in the above procedure that must be met for a 

regulatory meeting to be classified OAI. An OAI 

classification is most often made if an FDA 483, FDA 

4056, or state equivalent, has been issued and the 

documented evidence supports the action recommended 

unless the only significant observations are nonreportable, as specified by IOM 5.2.3.3, or in matters 

referred to OCI, as noted in “Referral to Office of Criminal 

Investigations (OCI)” above. An OAI classification may 

also be made when a state contract inspection is 

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FOOD AND DRUG ADMINISTRATION 

OFFICE OF REGULATORY AFFAIRS 

Document Number: 

FMD.086 

Revision #: 07 

Revised:12/14/2022 

FMD 86: Establishment Inspection Report Conclusions and Decisions Page 17 of 22 

determined to be violative and the State Liaison, in 

consultation with Compliance Branch and/or the State 

Contract Agency determine FDA follow-up or action is 

required. An OAI classification can be made only if the 

Inspection Conclusion is CI. 

Referred to State 

(RTS) 

Referred to state, local, or other federal office. This 

classification may be used when either there is no 

federal jurisdiction over the apparent violation in question 

or it is determined state action is the most efficient 

method of obtaining the establishment’s compliance with 

applicable federal laws, regulations, or administrative 

requirements. An RTS classification can be made only if 

the Inspection Conclusion is CI. 

C. Field Management Directive: The Field Management Directives (FMD) 

Manual is the primary vehicle for distributing procedural information on 

the management of Office of Regulatory Affairs (ORA) field activities. 

The manual is issued on the authority of the Associate Commissioner 

for Regulatory Affairs (ACRA) and is intended as INTERNAL 

instructions to field managers. Introduction to the Field Management 

Directives Manual | FDA 

Records 

The following systems contain the electronic records created during the 

inspection’s conclusion and decision process. 

A. FACTS 

B. CMS 

C. eSAF 

D. eNSpect 

Supporting Documents 

N/A 

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#

FOOD AND DRUG ADMINISTRATION 

OFFICE OF REGULATORY AFFAIRS 

Document Number: 

FMD.086 

Revision #: 07 

Revised:12/14/2022 

FMD 86: Establishment Inspection Report Conclusions and Decisions Page 18 of 22 

Document History 

Revision Status* 

(D, I, R) Date Author Name and Title Approving Official Name and Title 

6.0 R 01/28/2014 David K. Glasgow, Acting 

Deputy Director, OFFO 

Ellen Morrison, Assistant 

Commissioner for 

Operations 

07 R 12/14/2022 DCB Advisory Committee Judy McMeekin, ACRA 

* - D: Draft, I: Initial, R: Revision 

Change History 

Revision 

# Change 

3.0 

Provided the determination of appropriate classification, the follow-up with State Contract Agency to verify 

violations or appropriate regulatory follow-up is taken, and the authorization to insert “Final Decision” in FACTS 

to the District’s IB or Compliance staff for State Contract Inspections; Added OAI follow-up inspection 

recommended timeframes. 

4.0 

Revision to Referred to State District Decision, clarifying language to assist in the classification of state contract 

inspection reports and providing guidance on using Case Management System (CMS) to track inspections referred 

to the state for action. 

5.0 

The following clarifications/changes have been added: 

Section 5.1.,item (2) a) added “which will be entered after the action has been completed (Untitled Letter issued or 

Regulatory Meeting held)” 

Section 5.2, item 1) clarified “the compliance officer will enter the final decision in FACTS after the appropriate 

action has been taken or the decision to reclassify has been made.” 2) Added “and enter the Final Decision in 

FACTS upon completion of the action or reclassification.” 3) Added clarification “final classification will be 

entered by the compliance officer after any appropriate actions have been taken or the inspection re-classified.” 4) 

Clarified sentence “and take or recommend any appropriate action. The compliance office will enter the “Final 

Decision” in FACTS after any actions have been completed or the inspection re-classified.” 

Section 5.3, item 3) added “Final decisions will be entered in FACTS once the final District Decision has been 

determined. For OAI classification, the Final Decision shall not be entered until after the action has been taken.” 

6.0 Complete revision. Re-ordered for QMS SOP Template. Responsibilities and Procedures separated to provide 

clarity. 

07 

Complete revision. 

Reformatted to follow the inspectional flow and current naming/numbering scheme. Clarified timeframes for 

NAI/VAI endorsement to include both EIR writing and SCSO endorsement and added timeframes for Compliance 

Officers to complete final Division Decision. Included reference to CONOPS. Revised classification requirement 

for Untitled Letters and clarified classifications for regulatory meetings. Removed Refer to Center (RTC) 

classification option. Clarified ORA’s 6-month goal for OAI follow-up inspections apply to domestic inspections 

only and added exemptions for limited resources or high priority assignments. Added clarifications for state 

contract inspection classifications. Added requirement to monitor inspection status (6.7). Updated Definitions 

section. Removed reference to District and changed reference to Division or Program Divisions. 

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FOOD AND DRUG ADMINISTRATION 

OFFICE OF REGULATORY AFFAIRS 

Document Number: 

FMD.086 

Revision #: 07 

Revised:12/14/2022 

FMD 86: Establishment Inspection Report Conclusions and Decisions Page 19 of 22 

Attachments 

List of Advisory, Administrative, and Judicial Actions that could be 

recommended by the SCSO to the Compliance Branch. 

List of Attachments 

Attachment A - Advisory Actions............................................................................... 20 

Attachment B - Administrative and Judicial Actions .................................................. 21 

Attachment C - Other Procedures............................................................................. 22 

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FOOD AND DRUG ADMINISTRATION 

OFFICE OF REGULATORY AFFAIRS 

Document Number: 

FMD.086 

Revision #: 07 

Revised:12/14/2022 

FMD 86: Establishment Inspection Report Conclusions and Decisions Page 20 of 22 

Attachment A - Advisory Actions 

See Regulatory Procedures Manual Chapters 4 

Untitled Letter 

Warning Letter 

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FOOD AND DRUG ADMINISTRATION 

OFFICE OF REGULATORY AFFAIRS 

Document Number: 

FMD.086 

Revision #: 07 

Revised:12/14/2022 

FMD 86: Establishment Inspection Report Conclusions and Decisions Page 21 of 22 

Attachment B - Administrative and Judicial Actions 

See Regulatory Procedures Manual Chapters 5, 6, 7 

Application Action: e.g. {Recommendation for Denial of Pending Application 

(NDA, NADA, ANDA, PMA, etc.); Recommendation for Revocation of 

Approved Application (NDA, NADA, ANDA, PMA, etc.)} 

Banning 

Certification Withholding or Revocation Citation 

Civil Money Penalty 

Demand for Destruction or other Disposition 

Disqualification 

Administrative Detention 

Suspension of Registration 

Emergency Permit Disapproved 

Injunction 

License Action: e.g. {Denial, Suspension, or Revocation; Notice of Intent to 

Revoke License (for Biologics)} 

Prosecution 

Provisional Listing 

Recall (FDA mandatory) 

Remove from Shippers List 

Seizure/Detention 

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FOOD AND DRUG ADMINISTRATION 

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Document Number: 

FMD.086 

Revision #: 07 

Revised:12/14/2022 

FMD 86: Establishment Inspection Report Conclusions and Decisions Page 22 of 22 

Attachment C - Other Procedures 

See Regulatory Procedures Manual Chapter 10 

Regulatory Meetings 

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