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New Facility register with FDA

B

Barbaro Guerrero

Registered
#1
#1
We are a pharmaceutical company of Dietary Supplement and we are currently register with the FDA but we in a process of obtaining a new building at a different location.

Does the new building at a different location needs to be register separately with the FDA or Do we need to add it to our current registration ?

By the way, we are keeping both locations.
 
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Ajit Basrur

Ajit Basrur

Staff member
Admin
#2
#2
Refer my earlier post here: FDA Registration Requirements for Multiple Sites (elsmar.com)

In another document from FDA, it is stated, "Under the final rule’s definition of ‘‘establishment,’’ two establishments located 5 miles apart would not qualify as being at ‘‘one general physical location’’ and would therefore require two separate registrations. Each establishment would be associated with its own UFI and establishment registration number". See comment 46 on page 20 of 55 (around mid page in the middle column: 2016-20471.pdf (govinfo.gov)

So from your question, I do not know how far is the second location from the first one.
 
B

Barbaro Guerrero

Registered
#3
#3
Thanks for your help.

Our second location will be about 1/2 mile from the main building.

The new location will be our Main building (Headquarters). our old (current) location will be used for storage.

Do I have to get a new registration for the new Building ?
 
William55401

William55401

Quite Involved in Discussions
#5
#5
Good info above. Here's a rule of thumb I heard from an ex-FDA person. Is it a campus? Can you walk it? If you need to drive, it is not a campus and separate registration is indicated. HTH
 
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