FDA Software Related Warning Letters Excerpts

Search through SoftwareCPR's  archive of software and computer related FDA warning letters.

Search by any text for instance company name, device, citation, or any text of interest.

This can help you gain a better understanding of current FDA enforcement practices..

It can also help you recognize topics that you may need to clearly articulate to inspectors.

Our warning letter knowledgebase is updated  monthly from publicly available information only.

... or search warning letters by one of the following: 
Text: Search Tips
Date range: Start (ex: 1/31/98)
End (ex: 12/31/99)

If you want to see the entire warning letter go to the FDA below and search by the company name and if its not too old  you should find it.

To search FDA's Full Warning Letter database click FDA's FOI Electronic Reading Room: Warning Letters