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The New FDA Preventive Controls Inspection

Preventive Controls

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#1 MsFS

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Posted 22 May 2018 - 03:00 PM

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!

 

 



#2 chrcia

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Posted 22 May 2018 - 03:23 PM

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



#3 MsMars

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Posted 22 May 2018 - 05:00 PM

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



#4 mgourley

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Posted 22 May 2018 - 07:24 PM

This thread has my experience.

 

Marshall



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