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Required documents for FDA Withdrawal or Recall?


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#1 ncwingnut

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Posted 30 May 2019 - 08:22 PM

Good afternoon, all!

 

Does anyone know if there is a published list or templates of the documentation required by the FDA for a recall or withdrawal?  I'm thinking I saw some templates on the FDA site a few years ago, but I may be confusing with something else.  

 

Am updating our recall program and would like to include them.

 

Any help appreciated!

 

Lynn



#2 LostMyMind

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Posted 31 May 2019 - 12:22 PM

The FDA recently updated their web site, so some of their own links aren't valid anymore.  I found this site which appears to have the information you are looking for.  

 

https://www.fda.gov/...uidance-recalls

 

Hopefully it helps.

 

Thanks,

Todd






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