8 replies to this topic

[jimc52]

Hello everyone - I am in need of a pamphlet or write up on how to handle FDA inspections/inspectors when they arrive unannounced at our facilities. Does anyone have a lead on where I can find a document(s) like this? I have seen them in the past, but can't seem to find a google lead on it. If anyone has an internal generic procedure they would like to share, I would appreciate.

Thanks Much - Jim

[Simon]

Hello everyone - I am in need of a pamphlet or write up on how to handle FDA inspections/inspectors when they arrive unannounced at our facilities. Does anyone have a lead on where I can find a document(s) like this? I have seen them in the past, but can't seem to find a google lead on it. If anyone has an internal generic procedure they would like to share, I would appreciate.

Thanks Much - Jim

Hi Jim, welcome to the forums. I cannot offer you any experience of unannounced FDA audits, however unannounced audits are becoming commonplace throughout the industry with the likes of Tesco and also I believe you can choose to have unannounced audits as part of registration to some food safety management system standards such as BRC. I believe we will see more and more of these, so generally members will need to be prepared for the unexpected. So good question.

There was some previous discussion here on Unannounced Audits

Hopefully some members with direct experience will be able to help you further.

Regards,
Simon

[jimc52]

Thanks Simon. (I am here in the US)...hope someone will have something when they see this post. In further searching, I did discover some documents, and I may have to write this one from scratch. If I do, I will consider posting it here for others to use.

[Charles.C]

Dear Jim,

I'm not quite sure what you are asking for ?

Do you mean ideas for things like - maximising the delay in allowing any inspectors into the work area while you "tidy things up a bit" ?

Rgds / Charles.C

[tsmith7858]

I am actually in the process of re-writing our Regulatory Visits SOP and have found the FDA web site to be a good resource. They have the Inspectors Manual available in a .pdf and it gives you a great idea of what to expect.
Key Points of Interest
- Always check their ID and document the info
- FDA must present form 482 (explains why they are there)
- They must meet with a company official not just any employee
- They are limited in what records they can request
- There should be a method for handling samples (they must pay for samples)
- Never sign the report (Form 483) at the end, it is viewed as an acceptance and is not required - more documents will follow that you can sign!

- If they have a warrant, all bets are off, ignore the above and run for the hills!!!

Look up the manual for other tips and ideas.

TS

Edited by tsmith7858, 27 January 2010 - 07:29 PM.

[Simon]

I am actually in the process of re-writing our Regulatory Visits SOP and have found the FDA web site to be a good resource. They have the Inspectors Manual available in a .pdf and it gives you a great idea of what to expect.
Key Points of Interest
- Always check their ID and document the info
- FDA must present form 482 (explains why they are there)
- They must meet with a company official not just any employee
- They are limited in what records they can request
- There should be a method for handling samples (they must pay for samples)
- Never sign the report (Form 483) at the end, it is viewed as an acceptance and is not required - more documents will follow that you can sign!

- If they have a warrant, all bets are off, ignore the above and run for the hills!!!

Look up the manual for other tips and ideas.

TS

Is this it TS?
FDA Investigations Operations Manual

[Bob Bottel]

I have a procedure and a reference written covering the conduct of regulatory inspections. File is attached.

Bob

Attached Files

•  4.0_Regulatory_Inspection_Procedure___Generic.doc   979KB   56 downloads
•  4.0_Regulatory_Inspection_Procedure___Generic.doc   979KB   23 downloads

[tsmith7858]

Is this it TS?
FDA Investigations Operations Manual

Yes it is Simon, thanks.

[tsmith7858]

I have a procedure and a reference written covering the conduct of regulatory inspections. File is attached.

Contact bobbottel@earthlink.net with questions.

Bob

Great resource Bob, thanks for sharing this information.

The article is very good, particular the list of Do's and Don'ts. Jim should be able to pull most of his pamphlet directly from it.

TS