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  • 1.  FDA Investigator Overreach

    This message was posted by a user wishing to remain anonymous
    Posted 2 days ago
    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 yesterday

    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.  

    Peter Smith
    Smith GMP Consulting
    Narragansett, Rhode Island

  • 3.  RE: FDA Investigator Overreach

    Posted 20 hours ago

    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!

    Jonathan Amaya-Hodges
    Director, Technical Services
    Sharon MA
    United States