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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Procedure for Release of Establishment Inspection Report

Subject:
Procedure for Release of Establishment Inspection Report to the Inspected Establishment
Area:
Operations Management
Date Revised:
April, 1 1997

 

 

PURPOSE

This Field Management Directive (FMD) provides guidance and criteria for releasing a copy of the establishment inspection report (EIR) to the establishment that was the subject of an FDA or FDA-contracted inspection when the Agency determines the inspection to be "closed."

BACKGROUND

Under the Freedom of Information Act (FOIA) and FDA's regulations governing disclosures as set out at 21 C.F.R. Part 20, any inspection information including the list of inspectional observations (FDA-483), EIR, and the Agency's communication with the regulated establishment must be disclosed upon request by any member of the public. When requested according to established FOIA procedures, the Agency has made the inspection-related information available to requestors in accordance with the above statutory requirements. That is, the information that is not protected from disclosure by an FOIA exemption becomes releasable once the inspection is deemed closed by the Agency. Establishments wishing to obtain a copy of FDA's inspection report of their own establishment in the past were required to follow the same procedure. A number of industry associations expressed concerns that copies of EIRs may have been released to other requestors before the inspected establishments received the copies they requested. Consequently, these groups approached the Agency to request that it provide a copy of the EIR following an inspection of their facilities.

The Agency considered this request and determined that a copy of the EIR should be routinely provided to the inspected establishment once the Agency concludes that the inspection is closed. For the purpose of this directive, the term "closed" will have the same meaning as it has under 21 C.F.R. §20.64 (d)(3).

SCOPE

This directive became effective on April 1, 1997, and applies to inspections completed on or after the effective date. It encompasses inspections in ALL program areas, both domestic and international, performed by FDA or by any state/local authorities under contract with FDA.

Only the narrative portion of an EIR should be released to the establishment inspected. If the inspection is reported on a cover-sheet, only the inspection information contained in the endorsement section of the cover-sheet should be released. Attachments and exhibits to EIRs are excluded from disclosure under this directive.

PROCEDURE

As described in the Investigations Operations Manual, the investigator should identify the name of the most responsible individual located at the establishment inspected during the inspection. The report will be classified and endorsed by the district office according to existing procedures (See FMD 86).

Domestic EIRs

The district office that makes the initial inspection endorsement for domestic inspections will monitor and release the EIR under this directive. The endorsing 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. No information may be released to the establishment if it could not be released to that establishment in response to an FOIA request. For a domestic EIR that is referred to a Center, as in the case with inspections of bio-research facilities, the district office will release the EIR when the inspection is deemed closed by the appropriate Center reviewing office.

International EIRs

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. No information may be released to the establishment if it could not be released to that establishment in response to an FOIA request. 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.

All EIRs

The copy of the redacted EIR should be accompanied by a standard letter (See attached "model" letter ). The issuing office should send the package by an appropriate means, but should consider using certified mail if it may contain confidential commercial or trade secret information.

The issuing office should endeavor to provide a copy of the EIR and the letter to the inspected establishment at the earliest time possible once the inspection is deemed closed by the Agency.

 


 

Attachment: (On DHHS Letterhead)

[Date]

[Name]

[Address]

 

[Dear (Most responsible individual):]

We are enclosing a copy of the establishment inspection report (EIR) for the inspection conducted at your premises 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 new procedure is applicable to EIRs for inspections completed on or after April 1, 1997. For those inspections completed prior to the above date, a copy of the EIR may still be made available through the Freedom of Information Act (FOIA).

The Agency is working to make its regulatory process and activities more transparent to the regulated industry. Releasing this EIR to you is part of this effort. The copy being provided to you comprises the narrative portion of the report; it reflects 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 and, possibly, obtaining any additional information 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]