Hi,
We had checked with the CDRH Reg and Listing dept for facilities in US, we were asked a few questions
What are the addresses of each facility? How far apart are they from each other? Are they under the same ownership, quality systems, and management structures?
Based on the information we provided to them, their advice was ' the new facility would fall under the description of a campus setting and would not need to have a registration of its own'.
Regards,
Rashmi
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RashmiAdelaideAustralia
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Original Message:
Sent: 16-May-2019 09:49
From: Gregory Kleinert
Subject: FDA FURLS facility registration
Concur with your response. We have dual facilities less than a mile apart. I had registered both locations as separate entities and was informed that they can be "grouped" as a single site.
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Gregory Kleinert
Warrington PA
United States
Original Message:
Sent: 08-May-2019 07:47
From: Ginger Cantor
Subject: FDA FURLS facility registration
Hello Anonymous,
This would probably be able to registered as one facility. If you want to be sure, contact FDA DICE, but I did this a year or so ago and they told me things within a couple/few miles and under the same quality system would be one facility registration.
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Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com
Original Message:
Sent: 07-May-2019 15:23
From: Anonymous Member
Subject: FDA FURLS facility registration
This message was posted by a user wishing to remain anonymous
We have registered our main manufacturing facility in FURLS as per the Establishment registration and device listing requirement.
We own another smaller site that is located 0.8 miles away from the main manufacturing facility.
Are we required to register the other site separately or can we consider it under one facility registration?
Thank you.