Regulatory Open Forum

Is there anywhere to find previous FDA inspection reports?  There is a rumor that we had an FDA inspection a few years ago, however the only quality and regulatory resource working at our establishment at the time is no longer with the company.  We are not able to locate any documentation regarding the inspection at the time.  I am wondering if there is a website somewhere.  I tried the FDA resources and was not successful.

The FDA compliance dashboards are a useful resource to begin the search.

https://datadashboard.fda.gov/ora/cd/index.htm

Go to inspections and search your company name and you may find some history.

Is there anywhere to find previous FDA inspection reports?  There is a rumor that we had an FDA inspection a few years ago, however the only quality and regulatory resource working at our establishment at the time is no longer with the company.  We are not able to locate any documentation regarding the inspection at the time.  I am wondering if there is a website somewhere.  I tried the FDA resources and was not successful.

Is there anywhere to find previous FDA inspection reports?  There is a rumor that we had an FDA inspection a few years ago, however the only quality and regulatory resource working at our establishment at the time is no longer with the company.  We are not able to locate any documentation regarding the inspection at the time.  I am wondering if there is a website somewhere.  I tried the FDA resources and was not successful.

Back in the day you might have been able to just contact the presiding District Office; I would even give it a try today.  But officially nowadays, FDA will generally make you submit an FOIA request; even for your own report.

Note also that FDA might not yet have released the EIR if the inspection is one that is still open (e.g., if it involves OAI or VAI conditions not yet properly addressed and/or resolved with FDA by the firm). In such cases, FDA won't release the EIR until the objectionable conditions are addressed and/or resolved to FDA's satisfaction. If there is a chance that the prior inspectional observations weren't yet properly addressed and/or resolved by your firm, then you should consider proactively contacting the appropriate OMDRHO office to reengage and get things settled. If you need help with that kind of correspondence, feel free to reach out further to me as my firm specializes in such resolutions.

Is there anywhere to find previous FDA inspection reports?  There is a rumor that we had an FDA inspection a few years ago, however the only quality and regulatory resource working at our establishment at the time is no longer with the company.  We are not able to locate any documentation regarding the inspection at the time.  I am wondering if there is a website somewhere.  I tried the FDA resources and was not successful.

Hello Kevin, 

Which presiding District Office?

And what these terms stand for:
FOIA

OAI or VAI conditions

OMDRHO

Thanks

EIR

Original Message:
Sent: 23-Apr-2024 13:05
From: Kevin Randall
Subject: Locating previous FDA Inspection

Back in the day you might have been able to just contact the presiding District Office; I would even give it a try today.  But officially nowadays, FDA will generally make you submit an FOIA request; even for your own report.

Note also that FDA might not yet have released the EIR if the inspection is one that is still open (e.g., if it involves OAI or VAI conditions not yet properly addressed and/or resolved with FDA by the firm). In such cases, FDA won't release the EIR until the objectionable conditions are addressed and/or resolved to FDA's satisfaction. If there is a chance that the prior inspectional observations weren't yet properly addressed and/or resolved by your firm, then you should consider proactively contacting the appropriate OMDRHO office to reengage and get things settled. If you need help with that kind of correspondence, feel free to reach out further to me as my firm specializes in such resolutions.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 22-Apr-2024 17:24
From: Anonymous Member
Subject: Locating previous FDA Inspection

This message was posted by a user wishing to remain anonymous

Is there anywhere to find previous FDA inspection reports?  There is a rumor that we had an FDA inspection a few years ago, however the only quality and regulatory resource working at our establishment at the time is no longer with the company.  We are not able to locate any documentation regarding the inspection at the time.  I am wondering if there is a website somewhere.  I tried the FDA resources and was not successful.

The presiding "District Office" in today's terms will either be your local District Office or, for medical devices, one of the three OMDRHO offices (see attached maps). But I'm not sure what the OMDRHO-equivalent is for pharma or veterinary.

FOIA: Freedom of Information Act

OAI: Official Action Indicated

VAI: Voluntary Action Indicated

OMDRHO: Office of Medical Device and Radiological Health Operations

EIR: Establishment Inspection Report

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 23-Apr-2024 13:57
From: Anonymous Member
Subject: Locating previous FDA Inspection

This message was posted by a user wishing to remain anonymous

Hello Kevin, 

Which presiding District Office?

And what these terms stand for:
FOIA

OAI or VAI conditions

OMDRHO

Thanks

EIR

Original Message:
Sent: 23-Apr-2024 13:05
From: Kevin Randall
Subject: Locating previous FDA Inspection

Back in the day you might have been able to just contact the presiding District Office; I would even give it a try today.  But officially nowadays, FDA will generally make you submit an FOIA request; even for your own report.

Note also that FDA might not yet have released the EIR if the inspection is one that is still open (e.g., if it involves OAI or VAI conditions not yet properly addressed and/or resolved with FDA by the firm). In such cases, FDA won't release the EIR until the objectionable conditions are addressed and/or resolved to FDA's satisfaction. If there is a chance that the prior inspectional observations weren't yet properly addressed and/or resolved by your firm, then you should consider proactively contacting the appropriate OMDRHO office to reengage and get things settled. If you need help with that kind of correspondence, feel free to reach out further to me as my firm specializes in such resolutions.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 22-Apr-2024 17:24
From: Anonymous Member
Subject: Locating previous FDA Inspection

This message was posted by a user wishing to remain anonymous

Is there anywhere to find previous FDA inspection reports?  There is a rumor that we had an FDA inspection a few years ago, however the only quality and regulatory resource working at our establishment at the time is no longer with the company.  We are not able to locate any documentation regarding the inspection at the time.  I am wondering if there is a website somewhere.  I tried the FDA resources and was not successful.