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FDA Registration Requirements for Multiple Sites

#1
Hi. I would like some advice on how to handle the following situation:

Site A.- Is currently operating as the manufacturer/spec developer for a single medical device. Site A is now too small. As a result Site B is being built directly behind Site A (same driveway but different physical address). Site B will house the corporate Staff including QA. Site A will continue to manufacture the medical device product, although now, the R&D, QA, and executive staff will be located in Site B. As a result, design and post market activities will be managed from Site B.

Is there a need to change the registration for Site A to only Manufacturer and explicitly list Site B as the Spec Developer? I've been at larger organizations where "Corporate" is located across the country from the manufacturing sites and had separate registrations... but given the proximity of both buildings and the direct accessibility of all required resources, I wasn't sure if this was necessary.

Thanks in advance.
 

Ronen E

Problem Solver
Staff member
Super Moderator
#2
My intuition is to keep A and B as a single site (assuming that they operate under a single QMS); all that'd be required is to update the street (physical) address in A's registration, such that it includes B too (e.g. 16-18 noname street, Bestzoneever, Lala Land 99999).
 
#3
Thanks for the response... Yes, I should have stated that both buildings will be under the same QMS. With that, I guess the simple question for me to determine is if two addresses can be listed on 1 Establishment Registration. Based on your comments, this sounds like it may be possible.

Thanks again.
 

Watchcat

Quite Involved in Discussions
#4
As far as I know, the only thing FDA uses the registration address(es) for are correspondence and to find the registered facilities when it wants to inspect them. I'd worry more about any mail from FDA addressed to your executive staff going astray (because I've seen it happen when the C-Suite relocated just a few blocks away, sigh) than FDA inspectors not being able to find Site B if it shows up at Site A. I wouldn't expect any legal repercussions just because your registration neglects to mention that the spec developers are now in the next building. (Not materially false, misleading, adulterated, misbranded, etc.)
 

Ronen E

Problem Solver
Staff member
Super Moderator
#5
If two immediately-adjacent street numbers are listed as a single site, I don't see why the owner/operator of that site should advise the FDA which functions are in each number/building. I also don't think the FDA expects to know that other than when visiting.
 

Ajit Basrur

Staff member
Admin
#6
As per Self-Identification of Generic Drug Facilities, Sites, and Organizations , separate buildings within close proximity are considered to be at one geographic location or address if the activities in them are closely related to the same business enterprise; are under the supervision of the same local management; and are capable of being inspected by FDA during a single inspection.

Additionally, per SOP-000051, "Close Proximity" is defined as
i. Within a campus setting
ii. Within three miles driving distance of each other
iii. The buildings MUST be within the same State and the United States Judicial District Court area
 
#7
If two immediately-adjacent street numbers are listed as a single site, I don't see why the owner/operator of that site should advise the FDA which functions are in each number/building. I also don't think the FDA expects to know that other than when visiting.
Thanks for the advice!
 
#8
Can you advice how to start a facilities validation master plan for a new R&D and technical support facility to comply with ISO13485.
my company is a medical device manufacturer
 
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