A quick.note Anonymous,
If Company A is foreign, and Company B is A's Initial Importer, as well as the Distributor, then Company B is obligated to register with FDA as Initial Importer. "B" also has to review those complaints with regard to reportability (MDR) and report as necessary to FDA on the event. This would need to be worked out beyween A and B, as the report better be consistent if they both report. OR an option for A is to write to FDA and request a reporting waiver for themselves ("A"), stating they are assigning those MDR responsibilities on to "B". I would not recommend this, as it gives reporting control to your importer if you are a foreign company , but this waiver path does exist.
This MDR scenario is only true for Initial Importers.
I would say Distributors of any type.should retain complaint records per the Distribution Agreement. If I were "A", I would be periodically auditing them to see what complaints they had received, and if they had passed them on completely and in a timely manner spelled out in the agreement. If they are in fact doing MDRs, they have to keep the records for defined term as in 21 CFR 803.
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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: 12-Feb-2019 11:33
From: Anonymous Member
Subject: Distributor responsibility for complaint handling
This message was posted by a user wishing to remain anonymous
Company A's name is on the device. Company B is just a distributor
Original Message:
Sent: 12-Feb-2019 09:04
From: Anne LeBlanc
Subject: Distributor responsibility for complaint handling
Whose name is on the device?
For example, does the label say "Manufactured by Company A"? Or "Manufactured for Company B"?
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Anne LeBlanc
Manager, Regulatory Affairs
United States
Original Message:
Sent: 11-Feb-2019 18:30
From: Anonymous Member
Subject: Distributor responsibility for complaint handling
This message was posted by a user wishing to remain anonymous
Company A manufactures a finished device and sells it to Company B for final distribution in the US. Company B sells the device as is - no changes.
If Company B receives a complaint about the product and they have a process in place to forward all the info to Company A for complaint investigation, reportability assessment etc, are the activities performed by Company B technically considered part of the complaint handling process? If so, do those limited activities require Company B to register with FDA?
Note: Company A will maintain the complete complaint files
Is it acceptable for Company B to close their file once they have passed on the information to Company A or does the Company B file need to remain open until Company A has completed and closed the complaint.
Thanks for any assistance.