Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello,

We are working on our procedure for managing regulatory inspections.  We have not been subject to them in our current operations, but will be soon, as we are growing.  I have seen procedures that dictate that no documents issued during a regulatory inspection should be signed.  This includes FDA Forms 482, 483 (if applicable), sample receipt, etc. There is also the potential for only certain people within the organization to have signature authority for these types of documents (head of quality, head of regulatory, head of operations, plant manager, etc.)

Additionally, specifically for affidavits being issued or read aloud, I have seen procedures that direct employees to leave the room without acknowledging the existence of the the affidavit.  

Is there a standard industry wide?  Any thoughts or other experience would be super helpful, especially with any justification.  

Thanks in advance!

So you won't get asked to sign 482/483 - they are "issued" but no company signature is required - just the FDA one.

Anyway, I generally put this in a high level "managing inspections and audits policy." I guess it could be in an SOP too, but if you have a policy level, I'd at least put the affidavit thing there. If you have enough problems, FDA will likely ask you to sign them, and you don't want to do this according to any legal counsel I have ever known. However, if you can point to company policy where it says you are not allowed to do so, they generally back off (I had this happen personally). If you want to be more conservative, you can certainly say employees are not allowed to even read them.

While you are at it, you should also address things like NB audit reports (which I think do require a signature), who gets to decide how and if you annotation 483 observations, and whether and how photos are allowed [generally try to restrict them, but if FDA insists have someone from the company take "identical" photos] etc.

G-



------------------------------
Ginger Glaser RAC
Chief Technology Officer
MN
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Original Message:
Sent: 19-May-2021 11:13
From: Anonymous Member
Subject: Procedure for Signing Documents Issued During Inspections

This message was posted by a user wishing to remain anonymous

Hello,

We are working on our procedure for managing regulatory inspections.  We have not been subject to them in our current operations, but will be soon, as we are growing.  I have seen procedures that dictate that no documents issued during a regulatory inspection should be signed.  This includes FDA Forms 482, 483 (if applicable), sample receipt, etc. There is also the potential for only certain people within the organization to have signature authority for these types of documents (head of quality, head of regulatory, head of operations, plant manager, etc.)

Additionally, specifically for affidavits being issued or read aloud, I have seen procedures that direct employees to leave the room without acknowledging the existence of the the affidavit.

Is there a standard industry wide?  Any thoughts or other experience would be super helpful, especially with any justification.

Thanks in advance!

Agreed with Ginger as usual (she's very good at this stuff, and very smart by the way).  Adding a bit to the affidavit issue:  It has been my training from FDA regulatory counsel and my actual affidavit-related experience over the years that the firm should in fact leave the room without acknowledging the existence of the affidavit.  I've been instructed by FDA counsel, and have in real life practiced, to politely decline to read an affidavit, decline to hear an affidavit being read out loud, and certainly decline to sign an affidavit.  My understanding is that, as a general rule (exceptions may exist), there is virtually no benefit to a firm or individual for cooperating with an affidavit.  A fundamental purpose of an affidavit is to get a recipient to admit guilt, fault, wrong-doing, etc., and/or to admit facts that establish such violations/incriminations.  The affidavits are written by an FDA law enforcement officer and/or FDA counsel, yet in the first person as if the recipient themselves made the statements in the affidavit.  Then the recipient is asked to sign the statement.  It's definitely a bit creepy when an FDA investigator attempts to assert an affidavit.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
------------------------------

Original Message:
Sent: 19-May-2021 11:13
From: Anonymous Member
Subject: Procedure for Signing Documents Issued During Inspections

This message was posted by a user wishing to remain anonymous

Hello,

We are working on our procedure for managing regulatory inspections.  We have not been subject to them in our current operations, but will be soon, as we are growing.  I have seen procedures that dictate that no documents issued during a regulatory inspection should be signed.  This includes FDA Forms 482, 483 (if applicable), sample receipt, etc. There is also the potential for only certain people within the organization to have signature authority for these types of documents (head of quality, head of regulatory, head of operations, plant manager, etc.)

Additionally, specifically for affidavits being issued or read aloud, I have seen procedures that direct employees to leave the room without acknowledging the existence of the the affidavit.

Is there a standard industry wide?  Any thoughts or other experience would be super helpful, especially with any justification.

Thanks in advance!

I've never received an affidavit during an inspection, although I've only been through a handful. How common is this problem?

------------------------------
Renata Lavach-Savy
Associate Principal Regulatory Writer
Synchrogenix
Parsippany NJ
United States
------------------------------

Original Message:
Sent: 19-May-2021 15:10
From: Kevin Randall
Subject: Procedure for Signing Documents Issued During Inspections

Agreed with Ginger as usual (she's very good at this stuff, and very smart by the way).  Adding a bit to the affidavit issue:  It has been my training from FDA regulatory counsel and my actual affidavit-related experience over the years that the firm should in fact leave the room without acknowledging the existence of the affidavit.  I've been instructed by FDA counsel, and have in real life practiced, to politely decline to read an affidavit, decline to hear an affidavit being read out loud, and certainly decline to sign an affidavit.  My understanding is that, as a general rule (exceptions may exist), there is virtually no benefit to a firm or individual for cooperating with an affidavit.  A fundamental purpose of an affidavit is to get a recipient to admit guilt, fault, wrong-doing, etc., and/or to admit facts that establish such violations/incriminations.  The affidavits are written by an FDA law enforcement officer and/or FDA counsel, yet in the first person as if the recipient themselves made the statements in the affidavit.  Then the recipient is asked to sign the statement.  It's definitely a bit creepy when an FDA investigator attempts to assert an affidavit.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 19-May-2021 11:13
From: Anonymous Member
Subject: Procedure for Signing Documents Issued During Inspections

This message was posted by a user wishing to remain anonymous

Hello,

We are working on our procedure for managing regulatory inspections.  We have not been subject to them in our current operations, but will be soon, as we are growing.  I have seen procedures that dictate that no documents issued during a regulatory inspection should be signed.  This includes FDA Forms 482, 483 (if applicable), sample receipt, etc. There is also the potential for only certain people within the organization to have signature authority for these types of documents (head of quality, head of regulatory, head of operations, plant manager, etc.)

Additionally, specifically for affidavits being issued or read aloud, I have seen procedures that direct employees to leave the room without acknowledging the existence of the the affidavit.

Is there a standard industry wide?  Any thoughts or other experience would be super helpful, especially with any justification.

Thanks in advance!

Having spent 30 years with FDA's field organization (ORA), then working for a major consulting group and now operating independently, I can unequivocally endorse the previous comments.  Don't sign it, don't read it, don't listen to it being read and don't be helpful by pointing out "mistakes" or "inaccuracies" in the affidavit.  That last item can be a tactic to get you to initial and date any correction(s).  Finally, declining to sign an affidavit cannot be construed as a refusal to permit inspection.

------------------------------
Mark Lookabaugh
Principal Consultant
Stafford Springs CT
United States
mark.lookabaugh@parexel.com
------------------------------

Original Message:
Sent: 20-May-2021 08:28
From: Renata Lavach-Savy
Subject: Procedure for Signing Documents Issued During Inspections

I've never received an affidavit during an inspection, although I've only been through a handful. How common is this problem?

------------------------------
Renata Lavach-Savy
Associate Principal Regulatory Writer
Synchrogenix
Parsippany NJ
United States

Original Message:
Sent: 19-May-2021 15:10
From: Kevin Randall
Subject: Procedure for Signing Documents Issued During Inspections

Agreed with Ginger as usual (she's very good at this stuff, and very smart by the way).  Adding a bit to the affidavit issue:  It has been my training from FDA regulatory counsel and my actual affidavit-related experience over the years that the firm should in fact leave the room without acknowledging the existence of the affidavit.  I've been instructed by FDA counsel, and have in real life practiced, to politely decline to read an affidavit, decline to hear an affidavit being read out loud, and certainly decline to sign an affidavit.  My understanding is that, as a general rule (exceptions may exist), there is virtually no benefit to a firm or individual for cooperating with an affidavit.  A fundamental purpose of an affidavit is to get a recipient to admit guilt, fault, wrong-doing, etc., and/or to admit facts that establish such violations/incriminations.  The affidavits are written by an FDA law enforcement officer and/or FDA counsel, yet in the first person as if the recipient themselves made the statements in the affidavit.  Then the recipient is asked to sign the statement.  It's definitely a bit creepy when an FDA investigator attempts to assert an affidavit.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 19-May-2021 11:13
From: Anonymous Member
Subject: Procedure for Signing Documents Issued During Inspections

This message was posted by a user wishing to remain anonymous

Hello,

We are working on our procedure for managing regulatory inspections.  We have not been subject to them in our current operations, but will be soon, as we are growing.  I have seen procedures that dictate that no documents issued during a regulatory inspection should be signed.  This includes FDA Forms 482, 483 (if applicable), sample receipt, etc. There is also the potential for only certain people within the organization to have signature authority for these types of documents (head of quality, head of regulatory, head of operations, plant manager, etc.)

Additionally, specifically for affidavits being issued or read aloud, I have seen procedures that direct employees to leave the room without acknowledging the existence of the the affidavit.

Is there a standard industry wide?  Any thoughts or other experience would be super helpful, especially with any justification.

Thanks in advance!