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  • 1.  FDA Investigator Overreach

    This message was posted by a user wishing to remain anonymous
    Posted 26-May-2023 19:35
    This message was posted by a user wishing to remain anonymous

    How do you handle it when, even after your pushback, an FDA investigator still insists on reporting your firm as having violated FDA law or regulations, when in fact your firm hasn't?  Specifically, when no such law or regulatory requirement even exists, and/or where the FDA investigator is enforcing "best practices" as law/regulation? Such "reporting" means via corresponding 483 observations.  Bu also includes as written EIR "discussion items" which FDA's IOM instead seems to say shall be used only for deviations from specific laws, regulations, or official published guidance.



  • 2.  RE: FDA Investigator Overreach

    Posted 27-May-2023 01:13

    First, the FDA Investigator's observation is not the final agency decision. If you are unable to change the Investigator's mind and the issue finally appears on an FDA-483, you can respond (within 15 business days) and explain your point. Don't argue or say the Investigator was wrong - just explain.  The EIR, 483 and your response will be thoroughly reviewed by compliance officials before any further action is taken.  Most often off-the-wall observations disappear during the compliance review.  



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    Peter Smith
    Principal
    Smith GMP Consulting
    Narragansett, Rhode Island
    USA
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  • 3.  RE: FDA Investigator Overreach

    Posted 27-May-2023 12:30

    I concur with Peter: the observations of the inspector may be modified or removed by management, which is one reason why it takes so long for the EIR to become available.

    Additionally, it may be useful to have a third party, such as a regulatory consultant proficient in your type of products, to review the observations and assess your situation. An outside perspective often helps to confirm your thinking before taking additional action.

    If warranted, one could escalate to either management (at the relevant field office) or the ombudsman, however it is advisable to wait until the final report is issued before doing so.

    Finally, you could retain legal counsel to review and potentially take action, however there may be limited legal recourse, and pursuing that would likely entail lengthy litigation and sour any working relationship with the inspectors and FDA at large. Not to say that should never be pursued, but it's clearly a last resort.

    Best of luck!



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    Jonathan Amaya-Hodges
    Director, Technical Services
    Sharon MA
    United States
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  • 4.  RE: FDA Investigator Overreach

    This message was posted by a user wishing to remain anonymous
    Posted 29-May-2023 09:16
    This message was posted by a user wishing to remain anonymous

    That is aggravating.

    From the FDA Form 483 Frequently Asked Questions:

    An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment MAY constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts... The FDA Form 483 does not constitute a final Agency determination of whether any condition is in violation of the FD&C Act or any of its relevant regulations. The FDA Form 483 is considered, along with a written report called an Establishment Inspection Report, all evidence or documentation collected on-site, and any responses made by the company. The Agency considers all of this information and then determines what further action, if any, is appropriate to protect public health.


    On the one hand, if your inspector is a complete loose cannon, there will be a review of your polite, complete, and well-reasoned response, and the issue will be closed.

    On the other hand, if it sounds like the inspector might have a point, there will be a presumption that if something doesn't smell right, there's probably a problem lurking in there somewhere.

    If you're not following best practices, why not? Do you have a good reason, clearly defined? If your process isn't exactly wrong, but it may be a bit shaky, this might be a good opportunity to clean it up. How often do you have slip-ups? If they're suspicious about your processes, every slip-up will look like confirmation that you're out of control, and you will stay on the high-risk list for frequent inspection.




  • 5.  RE: FDA Investigator Overreach

    Posted 29-May-2023 19:02

    Hello Anon,

    Also completely agree with Peter about the approach.  While your organisation may not agree with the observation made, without seeing the actual observation statement and being there, might be difficult to agree or disagree.  Unfortunately regulations and regulatory requirements can have differences of interpretations, what is considered "current Good Manufacturing Practice", and stretching into opinions of how a company is operating within the laws and regulations.  It would be the best to respond to the Form 483 within 15 days as stated citing why the observation is not valid or incorrect.  Though be cautious because the persons reviewing the investigators report and the Form 483 were also not there present during the inspection, so the response should be respectful, well thought-out, constructive, unbiased, and explaining the situation thoroughly.  It is your opportunity to definitely provide much more detail surrounding the observation(s).

    Complaining or contacting the local office would only be advised if clearly there was blatant attitude, abuse, or not following company policy.  This can happen as well, but when recording observations there is still room for interpretation.  Generally, the US FDA investigators are trained similarly and according to the QSIT guide and compliance guide, but there are those which may have differing views or has "been around the block" with certain expectations ... right or wrong.



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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
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  • 6.  RE: FDA Investigator Overreach

    Posted 30-May-2023 11:43

    At a previous company, I ran into a situation in which the FDA inspector had taken a position regarding our products compliance to guidance documents and special controls versus design control requirements.  I had explained to the FDA inspector that our product met the requirements of the guidance document and the special controls in 21 CFR part 888.  The FDA Inspector said that we had not met the requirements of design validation.  I reviewed our position with the internal SME's.  I had reviewed the conversation and possible observation with our external consul and their SME's (several who had worked for the FDA).  They all agreed that our position was correct, and that the FDA inspector had strayed into the submission area versus compliance.  They proposed that I explain our position one more time.

    I explained the position one more time to the FDA inspector and the outcome was that we agreed to disagree.  The FDA inspector wrote it up on the FDA 483.  We responded to the observation and explained our position.  We knew that the person reviewing the response was not the FDA inspector, but a compliance officer at the district.  We wrote the response with that in mind and provided all of the details.  We never heard anything back on this issue from the FDA.  Now, I cannot speak to its removal from the EIR, because I had already left this company, but my sources have not told me that this issue reared its head again.

    I agree with the other explanations and opinions.  I also find it important to get the external assessment of the observation, just to make sure that the internal sources are not missing something.  I have had other situations in which we thought we had a strong position, but when we reviewed it with external consul they highlighted other areas that we had not considered.  This helped us to make sure we wrote a response to address these other areas and keep us on the right path with the FDA.

    I also want to highlight that the "c" in front of cGMP, means current.  The regulations came into place in 1997 and there has not been a lot of changing to the wording in the regulations, but we have also seen that the implementation and execution has changed over the years based on what the FDA deems the current best practice.  For example, in 1997 very few companies had a trace matrix for design input to design output and the connection to design verification and design validation.  Today, it has become the expectation when the FDA looks at design controls.  Now this paragraph may cause some debate, but in my experience, I have seen this evolution over the years.



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    Christopher Slimak
    Director, Design Assurance
    Warsaw IN
    United States
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  • 7.  RE: FDA Investigator Overreach

    This message was posted by a user wishing to remain anonymous
    Posted 30-May-2023 12:16
    This message was posted by a user wishing to remain anonymous

    In this scenario, the investigator aims to report the issue in the EIR as a "discussion item" with management.  The FDA's mandatory operating procedures in the IOM appear to state that discussion items shall only be for deviations from laws, regulations, or official published guidance.  But there is no law, regulation, or official guidance document requiring what the investigator is demanding.  Even though the firm repeatedly agreed to voluntarily do what the investigator has demanded, he still insists on reporting it as a discussion item (i.e., as a deviation from law and/or regulation).  The IOM prohibits investigators from being "overbearing or arbitrary", and also from "intimidation" and "strong-arm tactics".  Accordingly, the investigator in this instance is enforcing laws/regulations that don't exist, and also seems to be in violation of FDA's mandatory IOM (FDA says the IOM is the primary operation reference for FDA employees, and that adherence to the IOM is paramount to assure quality, consistency, and efficiency in field operations).




  • 8.  RE: FDA Investigator Overreach

    This message was posted by a user wishing to remain anonymous
    Posted 30-May-2023 14:12
    This message was posted by a user wishing to remain anonymous

    First I'd try a simple technical resolution as others have described.

    After that, if you still feel concerned about the apparent violation of appropriate inspection process, the ombudsman program might be a useful route to getting those things heard and addressed.

    https://www.fda.gov/about-fda/ora-ombudsman/ora-ombudsman-frequently-asked-questions




  • 9.  RE: FDA Investigator Overreach

    Posted 30-May-2023 17:33

    You can contact the US FDA Office of the Ombudsman



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    Aldwin Aldana
    Director, Clinical Quality Assurance (GCP)
    West Newton MA
    United States
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