Regulatory Open Forum

Can someone advise if responses to warning letters are made public? Is there a FDA site to review responses to warning letters? If so where is it?

Sent from my iPhone

Freedom of Information Act (FOIA) and FDA's regulations governing disclosures as set out in 21 CFR Part 20. Any inspectional records can be requested by any member of the public and will be disclosed after review for redaction according to the statute, regulations and policies. This includes information such as an FDA Form 483, EIR, and Agency communication with a regulated establishment. The following website contains a search tool for FDA letters with response or closeout letters https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters 

------------------------------
Juliane Carvalho RAC, MSc
Lead Regulatory Health Project Manager
United States
**My comments are an informal communication and represent my own best judgement. These comments do not bind or obligate the U.S. Food and Drug Administration**
------------------------------

Original Message:
Sent: 18-May-2023 08:30
From: Terry Van Liew
Subject: Question on warning letter communication

Can someone advise if responses to warning letters are made public? Is there a FDA site to review responses to warning letters? If so where is it?

Sent from my iPhone

Terry,

The Warning Letter itself is made public on the website Juliane provided and also the information she provided that responses and potentially other information can be obtained through the Freedom of Information.  Typically responses would be so heavily redacted even when you did get them, it probably is not too helpful to spend the time and energy requesting.  The Warning Letter itself usually has the information related to the observational item made regarding the company.  But no, responses to Warning Letters are not available through any public facing viewing or website.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 18-May-2023 16:59
From: Juliane Carvalho
Subject: Question on warning letter communication

Freedom of Information Act (FOIA) and FDA's regulations governing disclosures as set out in 21 CFR Part 20. Any inspectional records can be requested by any member of the public and will be disclosed after review for redaction according to the statute, regulations and policies. This includes information such as an FDA Form 483, EIR, and Agency communication with a regulated establishment. The following website contains a search tool for FDA letters with response or closeout letters https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters 

------------------------------
Juliane Carvalho RAC, MSc
Lead Regulatory Health Project Manager
United States
**My comments are an informal communication and represent my own best judgement. These comments do not bind or obligate the U.S. Food and Drug Administration**

Original Message:
Sent: 18-May-2023 08:30
From: Terry Van Liew
Subject: Question on warning letter communication

Can someone advise if responses to warning letters are made public? Is there a FDA site to review responses to warning letters? If so where is it?

Sent from my iPhone

I just want to second Richard's comment that even if you get the response through FOIA, it will very likely be so heavily redacted that it won't be of much use. I also don't know how prompt they are with such requests.

------------------------------
Rachel Thornton
Associate Director
Smyrna GA
United States
------------------------------

Original Message:
Sent: 19-May-2023 10:37
From: Richard Vincins
Subject: Question on warning letter communication

Terry,

The Warning Letter itself is made public on the website Juliane provided and also the information she provided that responses and potentially other information can be obtained through the Freedom of Information.  Typically responses would be so heavily redacted even when you did get them, it probably is not too helpful to spend the time and energy requesting.  The Warning Letter itself usually has the information related to the observational item made regarding the company.  But no, responses to Warning Letters are not available through any public facing viewing or website.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 18-May-2023 16:59
From: Juliane Carvalho
Subject: Question on warning letter communication

Freedom of Information Act (FOIA) and FDA's regulations governing disclosures as set out in 21 CFR Part 20. Any inspectional records can be requested by any member of the public and will be disclosed after review for redaction according to the statute, regulations and policies. This includes information such as an FDA Form 483, EIR, and Agency communication with a regulated establishment. The following website contains a search tool for FDA letters with response or closeout letters https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters 

------------------------------
Juliane Carvalho RAC, MSc
Lead Regulatory Health Project Manager
United States
**My comments are an informal communication and represent my own best judgement. These comments do not bind or obligate the U.S. Food and Drug Administration**

Original Message:
Sent: 18-May-2023 08:30
From: Terry Van Liew
Subject: Question on warning letter communication

Can someone advise if responses to warning letters are made public? Is there a FDA site to review responses to warning letters? If so where is it?

Sent from my iPhone

Check the following databases if your firm is listed, if so one can find the current status of your firm:
https://datadashboard.fda.gov/ora/index.htm
Warning letters and close out letters for firms:
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters

------------------------------
GRSAOnline
------------------------------

Original Message:
Sent: 18-May-2023 08:30
From: Terry Van Liew
Subject: Question on warning letter communication

Can someone advise if responses to warning letters are made public? Is there a FDA site to review responses to warning letters? If so where is it?

Sent from my iPhone

My response is related to a previous company.  Responses to a 483 or warning letter can be obtained through FOIA.  The company that is the subject of the 483 or the warning letter will be notified of the FOIA request and will have and don't quote me on this between five and ten days to redact the document and send it back to the FDA.  In this example, the company I was working for had FOIA requests within days of the issuance of the 483 and subsequently we were notified of FOIA requests for the 483 response.  Our response was approximately 16,000 pages with attachments, and we had a team go through the response in that short of time to redact the document.  The FDA inspection had not been classified yet and there was no decision yet on a warning letter by the FDA.  In this example, the FDA never issued a warning letter on this inspection.

------------------------------
Christopher Slimak
Director, Design Assurance
Warsaw IN
United States
------------------------------

Original Message:
Sent: 18-May-2023 08:30
From: Terry Van Liew
Subject: Question on warning letter communication

Can someone advise if responses to warning letters are made public? Is there a FDA site to review responses to warning letters? If so where is it?

Sent from my iPhone