FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

Document Number:

DIR-000067

Revision #: 00

Revised:

31 Jul 2019

Title: 

FMD-145 - Release of the Establishment Inspection Report (EIR) Page 1 of 5

Uncontrolled when printed on: 8/26/2019

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

Sections in This Document

1. Purpose .................................................................................................................................................... 2

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

3. Background............................................................................................................................................... 3

4. Responsibilities......................................................................................................................................... 3

5. Procedure ................................................................................................................................................. 4

6. References/Supporting Documents........................................................................................................... 4

7. Definitions/Glossary ................................................................................................................................. 5

8. Records..................................................................................................................................................... 5

9. Attachments............................................................................................................................................. 5

10. Document History ..................................................................................................................................... 5

11. Change History.......................................................................................................................................... 5
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

Document Number:

DIR-000067

Revision #: 00

Revised:

31 Jul 2019

Title: 

FMD-145 - Release of the Establishment Inspection Report (EIR) Page 2 of 5

Uncontrolled when printed on: 8/26/2019

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

1. Purpose

This Field Management Directive (FMD) provides criteria and instructions for 

releasing one copy of an Establishment Inspection Report (EIR), to the firm’s 

top management official or designee at the inspected firm, in accordance with 

the agency’s policy articulated at “Release of Establishment Inspection Report 

to the Inspected Establishment” 62 Fed. Reg. 18138, April 14, 1997.

2. Scope

To be eligible for EIR release under the process outlined by this FMD, the

inspection, domestic or foreign, performed by FDA or State and local 

authorities under contract with FDA, must be deemed closed in accordance 

with 21 C.F.R. § 20.64(d)(3). Cooperative agreement inspections performed 

under a grant from FDA are outside the scope of this FMD.

1

Inspections resulting in agency action (e.g., Warning Letter, Untitled Letter, 

Seizure) are not eligible for release until the inspection is closed in accordance 

with 21 C.F.R. § 20.64(d)(3). In the case of endorsed OAI inspections with 

Final Division Decisions, confirmation that no further agency action is planned 

from the appropriate Compliance Branch or Center must be obtained before 

release.

Inspections completed under the Mammography Quality Standards Act are 

released under separate procedures. 

Special domestic investigation activities like those identified with the FACTS 

Operation Code 13 are outside the scope of the this FMD as those activities do 

not generate EIRs.

If a Program or Office enters a formal agreement with another Center, such as 

a Concept of Operations, then the agreement’s release timelines will take 

precedence. All other requirements of this FMD will remain in effect.

 

1 In general, grantees own the rights in data resulting from a grant-supported project or program. See

Rights in Data, https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

Document Number:

DIR-000067

Revision #: 00

Revised:

31 Jul 2019

Title: 

FMD-145 - Release of the Establishment Inspection Report (EIR) Page 3 of 5

Uncontrolled when printed on: 8/26/2019

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

3. Background

In 1997, FDA announced in the Federal Register a policy that the narrative 

portion of the EIR should be routinely provided to the inspected establishment 

once the agency concludes that the inspection is closed.

Prior to instituting this practice, a number of industry associations expressed 

concerns that other requestors may receive copies of the EIR prior to the 

inspected establishment through the Freedom of Information Act (FOIA). These 

groups requested that FDA provide a copy of the EIR to the facility after the 

inspection. 

The agency considered this request and determined that a copy of the narrative 

portion of the EIR should be routinely provided to the inspected establishment

once the agency concludes that the inspection is closed. The policy stated that 

term “closed” will have the same meaning as it has under 21 CFR 20.64(d).

In tandem with publishing the policy, FDA instituted FMD-145. The original 

version of FMD-145 applied to all program areas and inspections, both 

international and domestic, performed by FDA or State and local authorities 

under contract with FDA. It required that a redacted copy of the EIR was sent 

via U.S. mail with a standard cover letter.

Subsequently, the agency reiterated its commitment to this policy in the notice 

“Expansion of Medical Device Industry Initiatives” 66 Fed. Reg. 800, Jan. 4, 

2001.

In the intervening decades, ORA provided inspected establishments with a 

redacted hardcopy of the EIR in accordance with the policy and this FMD and 

its subsequent revisions.

In 2019, ORA modernized the process it uses to comply with this policy 

directive by establishing a system to email the EIR narrative to the inspected 

facility.

4. Responsibilities

Domestic EIRs will be monitored and released by the appropriate ORA 

Program Division or FDA Center upon final compliance classification. Foreign 

EIRs will be released by the appropriate Center or Program Division 

responsible for the final compliance classification. The releasing office will 
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

Document Number:

DIR-000067

Revision #: 00

Revised:

31 Jul 2019

Title: 

FMD-145 - Release of the Establishment Inspection Report (EIR) Page 4 of 5

Uncontrolled when printed on: 8/26/2019

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

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 inspected 

establishment.

5. Procedure

ORA will develop operating processes and procedures for Program Divisions

to follow when issuing a copy of the EIR with FMD-145 Letters. These 

processes will ensure the following:

a. EIRs will be transmitted via electronic means when possible. The email 

will serve as the cover letter. When electronic means are not available, 

then EIRs should be transmitted in accordance with local procedures. 

b. FMD-145 letters shall be transmitted within 45 calendar days of the 

determination that the inspection is closed per 21 C.F.R. § 20.64(d)(3). 

The timeline will be expedited if requested by the Division of Information 

Disclosure Policy in response to a FOIA request.

c. FDA should adhere to standard operating procedures in redacting EIRs

and for correspondence.

d. Only the narrative portion of a redacted EIR or abbreviated report (i.e., 

Summary of Findings Report, State Inspection Checklist, etc.) should be 

released to the inspected firm. 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 FMD-145 cover letter.

6. References/Supporting Documents

a. “Release of Establishment Inspection Report to the Inspected 

Establishment” 62 Fed. Reg. 18138, April 14, 1997.

b. “Expansion of Medical Device Industry Initiatives” 66 Fed. Reg. 800, Jan. 

4, 2001.

c. 21 CFR Part 20 – Public Information

d. Investigations Operations Manual (IOM); Chapter 5.11

e. Field Management Directive FMD# 86 – Establishment Inspection 

Report Conclusions and Decisions
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

Document Number:

DIR-000067

Revision #: 00

Revised:

31 Jul 2019

Title: 

FMD-145 - Release of the Establishment Inspection Report (EIR) Page 5 of 5

Uncontrolled when printed on: 8/26/2019

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

f. Integration of FDA Facility Evaluation and Inspection Program for 

Human Drugs: A Concept of Operations

7. Definitions/Glossary

N/A

8. Records

a. Completed Cover Letter – record in CMS

b. Appropriately redacted copy of the EIR – record in CMS

9. Attachments

N/A

10. Document History

Revision

Status*

(D, I, R, 

C)

Date Author Name and Title Approving Official Name 

and Title

02 R 3/1/2012

Dennis Baker,

Regional Food & Drug

Director

Roberta Wagner,

Assistant Commissioner 

for Field Operations

03 R 25 JUNE 

2019

LORI HOLMQUIST

DIRECTOR OF 

INVESTIGATIONS, OHAFO

EAST 1

FMD 145 WORK GROUP 

TEAM

ORA PROGRAM 

REPRESENTATIVES

VINETTA HOWARD-KING

DIRECTOR , OFFICE OF HUMAN 

AND ANIMAL FOOD 

OPERATIONS (OHAFO) EAST

* D: Draft, I: Initial, R: Revision, C: Cancel

11. Change History

Revision Change

1.0 Original FMD on FDA.gov

2.0 Added process instructions and timelines in Section 5.0

03 Removed procedures and reflects implementation of an email-based system