Ora-wide procedure




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ORA-WIDE PROCEDURE


Food and Drug Administration

Office of Regulatory Affairs


ORA-QMIS Document Number:


FMD

Version #: 2.0


Page of

Release of Establishment Inspection Reports


(FMD# -145)

Date:

3/1/2012





Sections included in this document


  1. Purpose

  2. Scope

  3. Guidelines

  4. Background

  5. Procedure/Responsibilities

  6. References/Supporting Documents

  7. Definitions/Glossary

  8. Records

  9. Supporting Documents

  10. Attachments

Document and Change History


1.Purpose


This Field Management Directive (FMD) provides guidance and criteria for releasing a copy of an Establishment Inspection Report (EIR) to the establishment subject to an FDA or FDA contracted inspection.

2.Scope

The FMD applies to inspections which meet ALL of the following criteria:


    1. Unless excluded under paragraph 4, “Guidelines”, inspections in all program areas completed on or after the effective date of this directive, both foreign and domestic, led by or contracted for ORA/FDA.

    2. Inspections with an “Inspection Basis” classification of “Surveillance”.

    3. Inspections where no agency action is considered or pursued (i.e., inspections classified as No Action Indicated [NAI] or Voluntary Action Indicated [VAI] as classified by the District Inspection Branch).

    4. Inspections deemed closed in accordance with 21 C.F.R. § 20.64 (d)(3). For purposes of this directive, the agency deems these inspections to be “closed” upon supervisory review and entry of “Final District Decision” in the agency’s Firm Accomplishment and Compliance Tracking System (FACTS).

3.Guidelines


    1. Inspections resulting in agency action (i.e., Warning Letter, Untitled Letter, Seizure, etc.) are not releasable until the agency deems the “matter” to be closed in accordance with 21 C.F.R. § 20.64 (d)(3). As such these inspection results are exempt from this directive.

    2. Consult the Regulatory Procedures Manual (RPM) for guidance in releasing these inspection results to the subject firm.

    3. Inspections with an “Inspection Basis” classification other than “Surveillance” may be associated with ongoing compliance actions with the subject firm and may not be releasable until the agency deems the “matter” closed in accordance with 21 C.F.R. § 20.64 (d)(3). As such these inspection results are exempt from this directive.

    4. Only the narrative portion of an EIR or abbreviated report (i.e., Summary of Findings Report, State Inspection Checklist, etc.) should be released. Attachments and exhibits are excluded from disclosure under this directive. If the inspection is conducted and reported on a checklist only, as is the case with some state contract inspections, and the firm has already received a copy of the checklist, it is only necessary to send the firm a cover letter (model cover letter must be revised to reflect this).

    5. For the purpose of this directive, International EIRs will be monitored and released by the ORA headquarters or Center office responsible for maintaining the original establishment files. The releasing office will ensure that the EIR for the closed inspection is appropriately redacted under FOIA and 21 C.F.R. Part 20 before releasing a copy to the establishment inspected.

    6. International inspection reports for bio-research facilities, will be monitored and released by the appropriate Center when the inspection is deemed closed by the appropriate reviewing office.

    7. Due to the nature of the Mammography Quality Standards Act (MQSA) inspections, reporting, and follow-up required under U.S.C. Title 42, these inspections are excluded from this FMD.

4.Background

A number of industry associations expressed concerns that the agency was too slow in providing copies of EIRs which could have resulted in their release to other requestors prior to the inspected establishments receiving their copy in accordance with this directive. Consequently, these groups approached the Agency to request that it provide a copy of the EIR in a timely manner following an inspection of their facilities. The Agency considered this request and determined that a copy of the EIR or narrative inspection information should be routinely provided to the inspected establishment.



5.Procedure/Responsibilities

Districts/Centers will manage communication processes for the release of EIRs and a corresponding cover letter as appropriate for their internal processes. All districts/centers should comply with the following:


    1. It is the goal of this directive to improve the timeframe that the FMD 145 cover letter and EIR for NAI/VAI inspections are sent to firms. FMD 86 defines that the timeframe for EIR completion should not exceed 30 business days when no further action is expected. Initially, firms with inspection results which fall within the scope of this FMD will receive a first party redacted copy of the EIR within 30 business days from the date of the “Final Classification” with the goal of 20 business days to be reached within two years. For the purposes of this procedure, the date of “Final Classification” is the date when all Program Assignment Codes (PAC) for the inspection have received a Final Classification. Supervisory CSOs and/or COs must ensure the Final Decision block is checked for each PAC in FACTS and decision dates are correct. The most recent decision date will be used as the start date for timeframe reporting purposes. The date on the cover letter accompanying the EIR will serve as the end date for timeframe reporting purposes.

    2. Until such time that the agency data reporting system is capable of tracking the transmittal date of the cover letter and corresponding EIR, each District shall develop a method to track and trend compliance with this FMD.

    3. The FMD 145 cover letter and EIR shall be addressed to the top management official located at the inspected establishment (see Investigations Operations Manual (IOM) 5.10.4.3.4, paragraph 8).

    4. FMD 145 cover letters and EIRs shall be transmitted via regular U.S. mail or other economical means. No electronic transmission of EIR or cover letters is permissible at this time.


6.References/Supporting Documents


    1. Investigations Operations Manual (IOM)

    2. HHS FDA Docket Number 00N-1678 – Expansion of Medical Device Industry Initiatives

    3. Field Management Directive – Establishment Inspection Report Conclusions and Decisions (FMD# 86)

    4. 21 CFR Part 20 – FDA Freedom of Information (FOI) Regulations


7.Definitions/Glossary N/A

8.Records


    1. Completed Cover Letter.

    2. Appropriately redacted copy of the provided Establishment Inspection Report.

9.Attachments


a. Model Cover Letter, Attachment 1

FMD Document History/Change History


Version #

Status*

(D,I, R, C)



Date

Author Name and Title

Approving Official Name and Title

2.0

R

3/1/2012

Dennis Baker, Regional Food & Drug Director



Roberta Wagner, Assistant Commissioner For Field Operations

- D: Draft, I: Initial, R: Revision, C: Cancel
Version 1.0 – Original FMD on FDA.gov

Version 2.0 - Added process instructions and timelines in Section 5.0.





Attachment 1 - Sample Model Cover Letter

[Dear (Top Management Official):]

We are enclosing a copy of the establishment inspection report (EIR) for the inspection conducted at your premises located at [address] on [dates] [by/on behalf of] the U.S. Food and Drug Administration (FDA). When the Agency concludes that an inspection is "closed," under 21 C.F.R. 20.64 (d) (3), it will release a copy of the EIR to the inspected establishment. This procedure is applicable to EIRs for inspections completed on or after April 1, 1997.

The Agency continually works to make its regulatory process and activities more transparent for regulated industry. Releasing this EIR to you is part of that effort. The copy being provided to you contains the narrative portion of the report; it may reflect redactions made by the Agency in accordance with the FOIA and 21 C.F.R. Part 20. This, however, does not preclude you from requesting additional information available under FOIA.



If there is any question about the released information, feel free to contact [name] at [phone number] or write to: 


[address]

[Signed DD or designated authority]

Uncontrolled when printed on: 4/16/2016

For the most current and official copy, check the Master List




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