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The New FDA Preventive Controls Inspection

Started by , May 22 2018 03:00 PM
3 Replies

Just wanting to know if anyone else has had the privilege of having the FDA to perform their new multi-day Preventive Controls Inspection at their manufacturing facility?

 

They visited our facility and it lasted 5 days (quite a bit of a difference from the previous hours they'd spend in previous years).  I think that their expectations are a bit of a stretch for most manufacturing sites but would love to compare notes with someone else who had been through this process.

 

Thanks!

 

 

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Have not had the pleasure yet 5 days is a very long inspection

We have not had the pleasure yet either... but would love to hear more about your experience.  What's your process? 

This thread has my experience.

 

Marshall

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