7 replies to this topic

[qualityhr]

I am wondering if you are able to refuse an FDA auditor if they show up unannounced and the Quality Manager is not there. 

 

For reference, I work at a small production facility (10 people) and I am the only individual (as QM) that has the background to actually answer questions the auditor would have. I am the only one with access to the files, etc. 

 

In my research so far I haven't been able to find a clear answer to this other than the auditor will ask for the most responsible individual at the time and will wait until they arrive. 

 

Does anyone have any experience with a situation like this?

 

Thanks!

Sam 

[cookinmaple]

FDA I'm not familiar with, but with SQF you can submit blackout days if you know ahead of time. I don't believe you can turn them away without consequences. 

 

This is why most GFSI require a back up that is trained and ready at all times.

[Setanta]

You certainly don't want to refuse the FDA or USDA. You can request for a better time frame, but someone should be your back-up.

The Federal Food, Drug, and Cosmetic Act provides criminal penalties for refusal to permit a lawful inspection. POLICY: The legality of an FDA inspection, conducted at a reasonable time, and within reasonable limits, and in a reasonable manner, depends not on consent but on the validity of statutory authority

Edited by Setanta, 16 November 2023 - 05:43 PM.

[Brothbro]

There is some evidence in FDA guidance that would indicate that the FDA could see your situation as a reason to deny inspection. I've found some guidance for the drug/devices industry that mentions this scenario. During unannounced visits FDA inspectors do need to be ready for unforeseen circumstances like employee absences, schedule plant shutdowns, or big facility maintenance projects.

 

See lines 246 - 250 in my attached document:

DENIAL OF INSPECTION

Examples of potentially reasonable explanations that might result in the drugs or devices not being deemed adulterated under section 501(j) of the FD&C Act include, but are not limited to:

 

At the beginning of an unannounced inspection, appropriate personnel are not immediately available to accurately answer the FDA investigator’s questions.

 

I would suggest training all senior staff on the process of speaking with FDA auditors about this circumstance. Something like "Our quality manager is away at this time, and will return at X date. While we do have some insight into the quality program at our facility and participate in it, the quality manager is by far the best suited in our company to assist you during an inspection. For a timely inspection process we'd like to request you return at a later date when our QA manager is present."

 

This is just my hunch from reading some FDA guidances though, I would love to hear if anyone has any real experience with this scenario.

 

Attached Files

•  22 - Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection DGFI Clean 508 Complaint.pdf   470.55KB   14 downloads

[jfrey123]

Any refusal would be counted as a denial.  You can train your employees/peers to inform the auditor you're not on site, and that you control the files, and they may deem it reasonable for you to submit certain documents upon your return.  But generally if you're open for business, they're within their authority to inspect and anything perceived as impeding can get you in some hot water.

[MOHAMMED ZAMEERUDDIN]

Refusal of auditor is unacceptable. In the absence of QC Manager someone should look after the FSMS. It must be written in the Manual.

[sqflady]

In my experience, typically the plant manager/production manager takes over if quality is not there.  You either need a back-up or need to be on-call 24/7.  Obviously having a back-up is much more desired than the alternative.

[Dorothy87]

Hi Sam, 

 

Talk to your director about this situation.. this is quite common.. sometimes they have no idea about requirements, files, documents. Appoint someone like QA Assistant Manager and organise training. Then you will have a clear head during your holiday..