Regulatory Open Forum

 View Only

  • 1.  FDA Inspections and Request to sign affidavit

    This message was posted by a user wishing to remain anonymous
    Posted 30-Jan-2023 14:01
    This message was posted by a user wishing to remain anonymous

    Hello!
    I am new to the FDA inspection process. 
    I noticed in the corporate policy there is a reference instructing employees what to do when requested by FDA Inspectors to sign an affidavit.
    I assume this is based on the experience of such cases. 
    Can you please explain in what cases this could happen? Why would an inspector ask for an affidavit? 
    What is your experience with inspections and similar requests? 


  • 2.  RE: FDA Inspections and Request to sign affidavit

    Posted 30-Jan-2023 14:27
    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 2023 by ComplianceAcuity, Inc. All rights reserved.
    ------------------------------

    Original Message


  • 3.  RE: FDA Inspections and Request to sign affidavit

    Posted 31-Jan-2023 04:08
    Hello,

    As Kevin says, you should not read, nor be read to, nor sign an Affidavit - because as stated it is a very legal document.  Even if you or the organisation believe you have the full understanding of what is contained in an Affidavit, it could and can be used for other legal proceedings.  Most Affidavits an US FDA investigator would want you to sign if for the interstate commerce - the company is actually selling product across state lines which gives them jurisdiction to inspect and perform compliance related actions; this is most common.  But again signing or even acknowledging a document for shipping product interstate might lead to something more treacherous later on.  And definitely if you are presented with an Affidavit which is not related to interstate commerce shipping, there are probably a lot worse things going on.

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

    Original Message


  • 4.  RE: FDA Inspections and Request to sign affidavit

    Posted 31-Jan-2023 07:10
    Hello,

    I agree with Kevin.  Do not acknowledge, read, have read to you (listen), or sign an affidavit.  An affidavit is a law enforcement instrument that can be introduced in a legal action (civil or criminal) as fact.  Any attempt by the affiant to counter any statements or matters of fact presented in the affidavit can be considered as perjury.  As Kevin stated, these are not normally drawn up by the "friendly" FDA inspectors that you have been dealing with, but rather by FDA legal counsel, generally at FDA HQ.  Be assured, if you are presented with an affidavit, you/your company are in deep doo-doo and should immediately seek qualified legal counsel.

    James

    ------------------------------
    James R. Bonds J.D.
    Director Regulatory Affairs
    Atlanta GA
    United States
    ------------------------------

    Original Message


  • 5.  RE: FDA Inspections and Request to sign affidavit

    Posted 31-Jan-2023 11:42

    As and ex-FDA Investigator, I will add that Kevin's advice is spot on.  The affidavit is essentially a document attesting to the truth/accuracy of some situation be it simply an affidavit that has you attesting to the accuracy of certain documentation the Investigator has collected, or an admission of some compliance failure the Investigator is alleging occurred.  If the Investigator can get someone at the facility to essentially sign a document to admit to whatever he/she has found, all the better for them.  But there is no legal requirement for you to have to sign ANYTHING during an inspection. 

     

    Sent from Mail for Windows

     




    Original Message


  • 6.  RE: FDA Inspections and Request to sign affidavit

    Posted 31-Jan-2023 09:47
    Hi,
    I agree. In my experience, interstate affidavits are very common. Anything else, you should consult a lawyer. Here is an article, you might find helpful:

    https://www.meddeviceonline.com/doc/fda-inspections-how-to-respond-to-a-request-f-0001

    ------------------------------
    Maritza Sosa
    Principal Consultant
    Miramar FL
    United States
    ------------------------------

    Original Message


Related Content