FDA Establishment Registration for Testing Laboratories

SGquality

Quite Involved in Discussions
#1
Is it required for testing laboratories (for Microbiological analysis like Bioburden, Sterility Test etc.) to be registered with FDA for Establishment Registration ?

The subject in question is for laboratories within US.

Thank you
 
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MIREGMGR

#2
No. There is no applicable registration category.

The exception to this would be if the lab also offered services that are considered to be production steps, such as contract sterilization; or if the lab also makes finished devices of some kind.

Nelson Labs, for instance, is registered, and offers the kinds of lab services you mention, but their registration is as a contract sterilization provider.
 
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