Does the US FDA issue GMP certificates?

E

Ethan Loh

#1
Hi everyone,

Do anybody know why US FDA do not issues a GMP certificate or any form of certificate to a medical device manufacturer after the inspection?
 
Elsmar Forum Sponsor
M

MIREGMGR

#3
The FDA's stance is, a company meeting the definition of Establishment that is appropriately Registered and has Listed its products...both of which can be checked via publicly accessible databases...is to be assumed in compliance with the various applicable regulations unless the FDA has taken some action to indicate otherwise, which in most cases would be publicly notified via the periodic Warning Letters Update.
 
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