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How long does it take US FDA to issue a Warning Letter Close Out Letter

A

Arnthor

#1
Hello,

Anybody had any experience in handling US FDA warning letter?

How long does it take US FDA to issue a close out letter after they have received my firm corrective actions?

Will US FDA withdraw the warning letter from their website after they are happy with the corrective actions?

Please advice.
 

Gert Sorensen

Forum Moderator
Moderator
#2
Re: US FDA warning letter close out letter

Getting to close out of a warning letter can take anywhere from a few months up to 5-6 years. The real big issue is convincing them that the corrective actions have been implemented and are effective. This can be tricky depending on what the citations they raised are. Some of the warning letters that FDA has issued recently address interesting challenges like compiling retrospective DMR/DHF for products that have been on the market for up to 10 years. That may be considered a huge task. Other warning letters focus on the need for global corrective actions, that may also be nerve wrecking.

The warning letter will not be withdrawn from the website after the close out.

:bigwave:
 
#3
long long overdue answer: 6 months administrative time to close out the Warning Letter, after FDA has acknowledged that it is ready to do so based on your plants current condition of compliance.
 
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