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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Original Message:
Sent: 26-May-2023 23:56
From: Anonymous Member
Subject: FDA Investigator Overreach
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.
Original Message:
Sent: 26-May-2023 19:34
From: Anonymous Member
Subject: FDA Investigator Overreach
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.