FDA Registration for Mulitple Site Locations

A

Awerner

#1
Hello, I am new to this site, so please bear with me. My company, A, just accquired compnay B. The plan is to integrate both companies under one QSM. Currently both sites are under the same FDA site registration. Company A, doesn't perform any finished goods manufacturing (all done by a 3rd party contractor), but does do final product receiving and distribution. Company B, does do final product manufacturing onsite, as well as distributing the product (they will also start sending the FP to site A for distribution). Can both sites stay on the same FDA registration? Or since site B does manufacturing, does it need to have its own?
 
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A

ascherp

#3
It is true that both companies would need to be registered under a single Owner/Operator, but the questions seems to be whether two distinct establishment registrations would be required (under the same Owner/Operator). That depends on the specific activities that are performed.

Company B definitely needs its own registration, because of the final product manufacturing that is done on site. Please provide more information as to Company A's activities.

What does Company A's activity of "final product receiving and distribution" entail? Are acceptance tests and/or inspection performed for final release of product for distribution? Any repackaging and relabeling? Who controls (evaluates and approves) the 3rd party suppliers of the finished devices received and distributed by Company A? Are the devices manufactured by the 3rd party contractor to specifications provided by Company A?
 
A

Awerner

#4
Hello Ajit Basrur and ascherp, thank you for your responses.

ascherp, I believe you spelled out my question exactly. I understand that both sites need to have registered under the same "Operator/Owner" (as they are the same company), but my real question is should each site have they own distinct establishment registration?

I had thought that if any site performed manufacturing activities, such as site B, that this site would need to have their own establishment registration and site A and B would not be able to be under the same registration. Please confirm.

Please allow me to clarify site A's activities:
Site A performs incoming QC on all material components, then ships them to the 3rd party contractor. The FG are then received back from the contract facility, QC inspected (no release testing, only inspection) and released for distribution by Site A. The contract manufacturer uses Site A's specifications for all product manfacturing.
 
A

ascherp

#5
Hi Awerner, sorry for the delay in answering your question. According to your description of the activities performed, Company A will definitely need its own registration.
 
O

Oscar Wang

#6
Hi, Awerner:
In my opinion, not only site A but also your contractor supplier shall be registered at the same time. QMS requires that the design, purchasing, manufacturing, packaging and labeling, installation and servicing activities shall be under control. FDA will look for objective evidence to prove that.
 
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