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FDA Inspection Affidavit?

  • 1.  FDA Inspection Affidavit?

    Posted 03-Jun-2016 18:34

    Hey all,

           I am curious about peoples experiences regarding the FDA and their Inspections.  I have never heard of them obtaining an affidavit prior to issuing a warning letter, and yet that is what we are currently facing.  Our inspection isn't even closed out yet, and our inspector has already indicated we will be receiving a 483, as well as mentioning an affidavit. Has anyone had to deal with this?  any advice?  

    I am a first time manager, been here for 2 months, and right off the bat I noticed a number of changes that needed to be made ASAP... but I was not quick enough!!

    Thanks

    ------------------------------
    Steven Pavlik
    Corona CA
    United States
    ------------------------------


  • 2.  RE: FDA Inspection Affidavit?

    Posted 03-Jun-2016 19:11
    Steven,

    "...been here for 2 months, and right off the bat I noticed a number of changes..."

    If you verbally say what I suggest below, others at your firm may feel intimidated.  Thus, you may refer to the FDA manual.

    Basically, FDA inspector(s) may/can ask an affiant to sign the affidavit, the affidavit of which can be used in a court of law as "evidence."

    The affidavit is a sworn statement.  You may ask your counsel or your management to have your corporate policy to refuse to sign.

    When someone is asked to read and sign the affidavit, s/he may refuse to sign the affidavit by saying "I am not authorized to sign any affidavit according to our corporate policy or per our counsel's advice.  

    Thank you.  

    s/ David
    ______________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    Phone (Toll-Free): 1-(800) 321-8567



    "Knowledge is power only when it is practiced and put into action." - Regulatory Doctor

    NOTICE: This communication (including any attachments) may contain privileged or confidential information intended for a specific individual and purpose, and is protected by law. If you are not the intended recipient, you should delete this communication and/or shred the materials and any attachments and are hereby notified that any disclosure, copying or distribution of this communication, or the taking of any action based on it, is strictly prohibited.



    Original Message


  • 3.  RE: FDA Inspection Affidavit?

    Posted 03-Jun-2016 19:32

    Steven:  The general rule of thumb is that firms are under no obligation to sign or even read the affidavit.  It is generally recommended that firms decline to receive, review, or read the affidavit, and that this refusal be made "upon advice of corporate counsel", or "per corporate policy", etc.  The investigator will then note the refusal and the reason on the affidavit.  Upon a firm's refusal, the investigator will likely try to read the affidavit aloud, to which I have respectfully declined to listen in my previous inspections, without adverse consequence.

    Hope this helps,

    ------------------------------
    Kevin Randall, ASQ CQA, RAC (U.S., Canada, Europe)
    Principal Consultant
    ComplianceAcuity, Inc.
    Golden CO
    United States

    Original Message


  • 4.  RE: FDA Inspection Affidavit?

    Posted 05-Jun-2016 13:42
    Our policy was to leave the room and let the FDA inspector read the affidavit out loud to an empty room.



    Original Message


  • 5.  RE: FDA Inspection Affidavit?

    Posted 04-Jun-2016 08:15

    I've never been in the situation, but I've always been told that no one should sign an affidavit or other statement at the request of a regulatory inspector or auditor.

    As a proactive measure, RA usually recommends that the company adopt a policy addressing this situation, and that all employees be trained to politely decline any such requests, citing the company policy, and refer the inspector or auditor to their supervisor.  I think in most cases the inspector or auditor would then let it go, but if not, the supervisor refers it to their supervisor, who does the same, until the request reaches the top of the management chain, where it is rejected.

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com

    Original Message


  • 6.  RE: FDA Inspection Affidavit?

    Posted 04-Jun-2016 14:03

    Further to your comments about the affidavit in relation to a Warning Letter and the 483:

    Remember that a 483 is different than a Warning Letter.  Also, the issuance of a 483 doesn't automatically mean there will be a Warning Letter.  Similarly, the mention of, or execution of, an affidavit doesn't necessarily mean there will be a Warning Letter.  I've had clients not get a Warning Letter even though they were presented with an affidavit.  Indeed, the FDA has a number of trigger criteria for Warning Letters.  But an affidavit is not, in and of itself, one of the triggers.  Unless the objectionable conditions cited by the Investigator overlap with the Warning Letter criteria, then your firm can avoid a Warning Letter as long as the firm manages the remainder of the inspection properly, and then properly responds to the 483 in accordance with FDA's expectations.  And oftentimes, even if there are Warning Letter triggers amidst the 483 observations, your firm's proper approach and interaction with the Agency during the coming days, weeks, and months can avert an otherwise imminent Warning Letter.  I've had client scenarios before where the Agency was threatening/pondering a Warning Letter, but then rescinded because of the firms' proper responses to the objectionable conditions.  The thing with which firms tend to struggle is that the FDA's expectations are rather "unwritten/unsaid rules", which the FDA finds necessary in order not to compromise the impartiality/objectivity of the FDA inspection/enforcement process.

    Hope this helps,

    ------------------------------
    Kevin Randall, ASQ CQA, RAC (U.S., Canada, Europe)
    Principal Consultant
    ComplianceAcuity, Inc.
    Golden CO
    United States

    Original Message


  • 7.  RE: FDA Inspection Affidavit?

    Posted 06-Jun-2016 10:12

    Hi All,

    Without prying into the specific situation which generated Mr. Pavlik's original inquiry, I am wondering under what types of circumstances an FDA inspector may request signature of an affidavit?  I will be formulating a policy for my organization as recommended.

    Thanks,

    Mitch

    ------------------------------
    Mitchell Johnson
    Arden Hills MN
    United States

    Original Message


  • 8.  RE: FDA Inspection Affidavit?

    Posted 06-Jun-2016 10:42
    You may refer to the IOM Chapter 4. Otherwise, you may download the IOM Chapter 4 in PDF at the bottom of my training seminar here >>

    David



    Original Message


  • 9.  RE: FDA Inspection Affidavit?

    Posted 06-Jun-2016 10:47

    Wow thank you all for the advice.  Being rather new to this position, this kind of experience was far from what I expected.  I had been aware of the way 483's worked, just hadnt been on the receiving end of one in the past.  The affidavit mention is a first for me as well!  In researching this over the weekend, and with all of your advice as well, I think I will write up a policy for this as well and suggest that we not sign or acknowledge the affidavit, regardless of its potential validity.  Politely of course.  

    Thank you Kevin, I had originally assumed a warning letter would be a sure thing if they were going as far as an affidavit, you clarified that perfectly for me.

    ------------------------------
    Steven Pavlik
    Corona CA
    United States

    Original Message


  • 10.  RE: FDA Inspection Affidavit?

    Posted 06-Jun-2016 12:34

    Mitch:  Please take a look at my additional comments about the general purposes of an affidavit.  Also, by policy, the FDA always seeks to get the affiant to sign the affidavit.  A signature from the affiant is always sought.

    ------------------------------
    Kevin Randall, ASQ CQA, RAC (U.S., Canada, Europe)
    Principal Consultant
    ComplianceAcuity, Inc.
    Golden CO
    United States
    www.complianceacuity.com

    Original Message


  • 11.  RE: FDA Inspection Affidavit?

    Posted 06-Jun-2016 12:24
    Edited by Kevin Randall 06-Jun-2016 12:29

    To be sure I didn't understate the significance of an affidavit, let me clarify further:  Even though an affidavit is not, in and of itself, a Warning Letter trigger, this does not mean the firm is out of danger. If an FDA Investigator is pursuing an affidavit, then it means that he/she has sampled the firm's products during the inspection and discovered objectionable conditions suggesting that the products are in violation of the law (i.e., the FD&C Act), and that the violations are of regulatory significance.  So if an affidavit is being sought, then a Warning Letter is a reasonable possibility, yet can, in many cases, be averted if the firm plays its cards right in the coming days, weeks, and months.

    In addition to the purposes in my preceding paragraph, the overall purpose of an affidavit is to get statements from the person(s) directly involved with the violative product, or who are aware of interstate commerce of the product (thereby establishing FDA jurisdiction), or who know facts relevant to the violative condition of the product.  The FDA uses affidavits (Form FDA 463a) to officially document those facts and get the affiant (i.e., the person named in the affidavit) to sign the affidavit in order to assign responsibility for the violations, establish self-incrimination, and so that the affiant can ultimately be called upon to testify in court during an FDA legal action against the firm (if such legal actions became necessary).  An affidavit bolsters FDA’s case and is a tool to guard against the affiant later changing his/her testimony.

    ------------------------------
    Kevin Randall, ASQ CQA, RAC (U.S., Canada, Europe)
    Principal Consultant
    ComplianceAcuity, Inc.
    Golden CO
    United States
    www.complianceacuity.com

    Original Message


  • 12.  RE: FDA Inspection Affidavit?

    Posted 06-Jun-2016 12:59

    By the way, I am not an attorney, and my guidance in this forum does not constitute legal advice.  However, I noted that Mark DuVal (an attorney specializing in FDA law) made a comment over the weekend in response to this discussion, but misplaced the comment in a different discussion thread.  I'll contact Mark and have him reply in this thread so we can get some more qualified legal advice into the thread.

    ------------------------------
    Kevin Randall, ASQ CQA, RAC (U.S., Canada, Europe)
    Principal Consultant
    ComplianceAcuity, Inc.
    Golden CO
    United States
    www.complianceacuity.com

    Original Message


  • 13.  RE: FDA Inspection Affidavit?

    Posted 06-Jun-2016 13:31

    Hi Kevin,

         You did not undersell it, but the clarification is certainly welcome.  I did see Marks post, it found its way to my email.  It seems to be further evidence that everyone here is in agreement on the proper handling of an affidavit.

    "Do not read or have read to you, review or touch an affidavit much less sign one.  Don't let them leave it behind with you. You have absolutely no obligation to sign an affidavit.  FDA inspectors in their Inspections Operations Manual (IOM) are taught to request all sorts of things to which they are not entitled because it is deemed consent if you acquiesce.  They are used to manufacturers politely but firmly declining on the grounds of company policy or at the direction of legal/regulatory counsel.  These requests have now become routine. It does not necessarily mean regulatory action.  An affidavit makes FDAs life easier if they should decide to take any action.  It is a self-incriminating document because they have carefully worded the facts and possibly legal cobclusions to their advantage.  It would be best in the future if you had a company policy in place that covers this specific matter and inspections generally.  Let me know if you need such a policy and an inspection tips document. 

    Mark DuVal, J.D., FRAPS

    President & CEO

    DuVal & Associates, P.A.

    Duval@duvalfdalaw.com

    612.338.7170 x1"

    ------------------------------
    Steven Pavlik
    Corona CA
    United States

    Original Message


  • 14.  RE: FDA Inspection Affidavit?

    Posted 06-Jun-2016 13:41

    Oops, sorry about the redundant content as we passed each other in hyperspace...

    Cheers,

    Kevin

    ------------------------------
    Kevin Randall, ASQ CQA, RAC (U.S., Canada, Europe)
    Principal Consultant
    ComplianceAcuity, Inc.
    Golden CO
    United States
    www.complianceacuity.com

    Original Message


  • 15.  RE: FDA Inspection Affidavit?

    Posted 06-Jun-2016 13:27

    Mark gave me his permission to reprint his comments here:

    "...Do not read or have read to you, review or touch an affidavit much less sign one.  Don't let them leave it behind with you. You have absolutely no obligation to sign an affidavit.  FDA inspectors in their Inspections Operations Manual (IOM) are taught to request all sorts of things to which they are not entitled because it is deemed consent if you acquiesce.  They are used to manufacturers politely but firmly declining on the grounds of company policy or at the direction of legal/regulatory counsel.  These requests have now become routine. It does not necessarily mean regulatory action.  An affidavit makes FDAs life easier if they should decide to take any action.  It is a self-incriminating document because they have carefully worded the facts and possibly legal cobclusions to their advantage.  It would be best in the future if you had a company policy in place that covers this specific matter and inspections generally.  Let me know if you need such a policy and an inspection tips document..."

    Mark DuVal, J.D., FRAPS

    President & CEO

    DuVal & Associates, P.A.

    Duval@duvalfdalaw.com

    612.338.7170 x1

    ------------------------------
    Kevin Randall, ASQ CQA, RAC (U.S., Canada, Europe)
    Principal Consultant
    ComplianceAcuity, Inc.
    Golden CO
    United States
    www.complianceacuity.com

    Original Message


  • 16.  RE: FDA Inspection Affidavit?

    Posted 09-Jun-2016 09:33

    Also from me.  Thank you all for your time and the interesting discussion.  I will weave these suggestions into our policy. 

    Best regards,

    Mitch

    ------------------------------
    Mitchell Johnson
    Arden Hills MN
    United States

    Original Message


  • 17.  RE: FDA Inspection Affidavit?

    Posted 09-Jun-2016 11:39
    It has been interesting to read the subsequent posts after mine.

    This is to add one point for your consideration when developing your policy.

    Please think about who FDA investigators are - some are experienced in industry, and others are not.  Some know admin or legal proceedings dangerous enough to get emotional. 

    After all, they are our respected parties not friends.

    Thus, when we refuse to sign or listen to those presenting affidavit(s), please exercise your discretion and kindly state your grounds for refusal.  No reason to choose to be annoying or intimidating! 

    If you are real professional and are well aware of the matter, no reason to get/feel emotional, annoying or intimidating during FDA inspection proceedings. 

    Thank you.  

    s/ David
    ______________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    Phone (Toll-Free): 1-(800) 321-8567



    "Knowledge is power only when it is practiced and put into action." - Regulatory Doctor

    NOTICE: This communication (including any attachments) may contain privileged or confidential information intended for a specific individual and purpose, and is protected by law. If you are not the intended recipient, you should delete this communication and/or shred the materials and any attachments and are hereby notified that any disclosure, copying or distribution of this communication, or the taking of any action based on it, is strictly prohibited.



    Original Message


  • 18.  RE: FDA Inspection Affidavit?

    Posted 10-Jun-2016 09:46

    Yes, David.  My perspective on the value of having a written policy in place prior to an inspection or audit is that:

    1)  It's not personal. It's not that the employee has decided that they personally will not sign; it's just company policy.  It is not that no one will sign an affidavit for this particular agency, nor for inspector personally; it's just company policy.  Any inspector or auditor from any agency would be told the same thing.

    2)  It's not specific.  It is not just for this inspection, nor does it have anything to do with what the affidavit says (i.e, it doesn't mean the employee or the company is worried about the findings of this particular inspection, nor about the content of the affidavit), it's just company policy.

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com

    Original Message


  • 19.  RE: FDA Inspection Affidavit?

    Posted 16-Jun-2016 08:31

    I completely agree with Julie - having a policy/procedure makes it easy. I'll share a nearly verbatim conversation I had a few years ago.

    Inspector - "I want to talk about having you review & sign an affidavit"

    Me - "You know I can't discuss this with you, right?"

    Inspector - "Oh, come on, just read it, I spent so much time writing it."

    Me - "I can't. We have a company policy that says I can't. You don't want me to fail to follow our policy, do you?"

    Inspector - "Do you have a copy of that policy?"

    Me - "yep [note - I had seen this coming and pulled a copy ahead] - see there in section 5"

    Inspector - "OK, I'll put this away then"

    That's it - makes it completely not confrontational.

    ------------------------------
    Ginger Glaser RAC
    Vice-President, Quality and Regulatory Affairs
    Maplewood MN
    United States

    Original Message


  • 20.  RE: FDA Inspection Affidavit?

    Posted 17-Jun-2016 17:08
      |   view attached
    For many justifiable reasons, I would suggest that the FDA should consider my proposed statements attached in this post.  



    Original Message