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FDA Audit - need a 'heads up' on what to expect?


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#26 fgjuadi

fgjuadi

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Posted 12 February 2015 - 11:51 AM

Hi guys,

 

How do you all get the FDA audit?  Is there any application for this or is FDA just decided which facility to audit?

My company, which is a foreign food ingredient / dietary supplement manufacturer, would like to do such audit as we have found other manufacturers mentioned on their website that they have registered with the U.S. FDA and successfully inspected by the FDA for the manufacture of dietary supplements in accordance with 21CFR111.

 

We have registered our facility but I have no clues how to apply for the FDA inspection.

Can someone give me some clues on this?  Thank you so much.

I'm not an expert on this, but maybe this website can help you, or point you in the right direction -
http://www.fda.gov/F...s/ucm211823.htm

http://www.fda.gov/F...s/ucm196386.htm

 

FDA inspection isn't something people are generally excited to do or trying to sign up for over here  :lol: , so I'm not fmailiar with any way to apply.  I'm guessing that the FDA woudl discourage this as their audits are enforcement  related and generally unannounced in the states.  It may be different overseas with the high cost of travel? 


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