Warning Letter 1999 - Where does the FDA make older warning letters available?

paulag

Involved In Discussions
#1
Hi All,

Where does the FDA make older warning letters available, if at all? Looking for a medical device related Warning letter issued September 1999.

Hope you can provide a link, and thanks in advance!
 
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nvquality

Starting to get Involved
#2
I do believe they archived anything earlier than 2005 and you'd probably need to do an FOI (Freedom of Information) request. I found an interesting WSJ article from 2015 regarding this change, sorry I can't post link but you can probably do a web search for "wsj" and what-did-the-fda-do-with-some-of-those-old-warning-letters".

FDA does have an archive page "FDA.gov Archive" but appears limited when I tried a search, but you could try it. It comes up as an option when it returns zero search results in the Warning Database.
 
#4
I do believe they archived anything earlier than 2005 and you'd probably need to do an FOI (Freedom of Information) request. I found an interesting WSJ article from 2015 regarding this change, sorry I can't post link but you can probably do a web search for "wsj" and what-did-the-fda-do-with-some-of-those-old-warning-letters".
Direct link as per the above suggestion:

What did the FDA do With Some of Those old Warning Letters?
 

paulag

Involved In Discussions
#5
Thank you all!

I found the archive, but it only goes back to 2005. For anything older than that, there is only an enforcement overview, which does not even work. So, it will have to be a FOIA request
 
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