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Manufacturer address on the label

monoj mon

Starting to get Involved
#1
Hi All,

I tried to find whether this exact issue has been discussed here previously or not, but couldn't find an answer which match with my current question. So decided to start a new discussion thread.

We have two facilities in the same country, Facility A and Facility B separated by nearly few hundred km and they are within driving distance. The Facility A is our head office where all the administrative activities are being done and is also the owner operator in the registration listing. However, Facility B is our manufacturing plant where we manufacture, sterilize, package and ship all our products. For all our devices to be distributed worldwide, we put the address of Facility A as a "Manufacturer" on the label as well as in the market authorization applications such as CE, 510(k) etc. But, we definitely mention about Facility B in those regulatory applications as the facility where all the devices are manufactured, sterilized and packaged. Also, in the GUDID we have identified the Facility A as a manufacturer and included its DUNS number. But, in the registration/listing website we have clearly defined functions of both the facilities as "Facility A - Specification Developer" and "Facility B-Manufacturer". So, in summary, for the customer and end user, Facility A is legally bound for everything and will be responsible for anything related to the device whereas the device is actually manufactured in Facility B and it "will get" audited/inspected by regulatory authorities.

Facility B is very new and yet to receive any inspection. So, does this labeling scenario and regulatory pathway make sense and is it an appropriate pathway! Will it be a misbranding!OR does this make Facility A to change from "Manufacturer" to "Manufactured for" on the label! Or should we just put the address of the Facility B where the devices are physically manufactured?
 
#2
The regulatory pathway makes sense although it's a little convoluted.
You could also consider putting Facility A as the legal manufacturer for all purposes and intend, and treat Facility B as a critical supplier /sub-contract site that need not be mentioned on the IFU or system label. In this pathway you may only need to make the distinction in the GUDID and/or FDA listing information.

Let's see what others can contribute to the discussion.
 

Ronen E

Problem Solver
Staff member
Super Moderator
#4
Hi All,

I tried to find whether this exact issue has been discussed here previously or not, but couldn't find an answer which match with my current question. So decided to start a new discussion thread.

We have two facilities in the same country, Facility A and Facility B separated by nearly few hundred km and they are within driving distance. The Facility A is our head office where all the administrative activities are being done and is also the owner operator in the registration listing. However, Facility B is our manufacturing plant where we manufacture, sterilize, package and ship all our products. For all our devices to be distributed worldwide, we put the address of Facility A as a "Manufacturer" on the label as well as in the market authorization applications such as CE, 510(k) etc. But, we definitely mention about Facility B in those regulatory applications as the facility where all the devices are manufactured, sterilized and packaged. Also, in the GUDID we have identified the Facility A as a manufacturer and included its DUNS number. But, in the registration/listing website we have clearly defined functions of both the facilities as "Facility A - Specification Developer" and "Facility B-Manufacturer". So, in summary, for the customer and end user, Facility A is legally bound for everything and will be responsible for anything related to the device whereas the device is actually manufactured in Facility B and it "will get" audited/inspected by regulatory authorities.

Facility B is very new and yet to receive any inspection. So, does this labeling scenario and regulatory pathway make sense and is it an appropriate pathway! Will it be a misbranding!OR does this make Facility A to change from "Manufacturer" to "Manufactured for" on the label! Or should we just put the address of the Facility B where the devices are physically manufactured?
Please clarify. You are talking about two facilities, but are these facilities part of the same company or not?
And also important - Do both sites operate under one QMS, or each have their own QMS?
 

monoj mon

Starting to get Involved
#6
The regulatory pathway makes sense although it's a little convoluted.
You could also consider putting Facility A as the legal manufacturer for all purposes and intend, and treat Facility B as a critical supplier /sub-contract site that need not be mentioned on the IFU or system label. In this pathway you may only need to make the distinction in the GUDID and/or FDA listing information.

Let's see what others can contribute to the discussion.
Thank you for your reply and valuable input. Facility A is indeed mentioned everywhere else (except for the registration listing purpose) as the legal manufacturer. I am just curious will it be appropriate if we mention Facility B as the critical supplier/sub-contract site as both the facilities are under the name of same company, only difference is that they are located in different cities.
 

monoj mon

Starting to get Involved
#9
The same QMS could have two or more different scope statements.
Thanks John. In our QMS both the facilities are clearly mentioned and their activities are clearly identified. My question is "will it be appropriate if we mention Facility A (the head office) as the manufacturer on the labeling even though the Facility B is the actual manufacturing site!". Also repeating here for clarification, both the facilities are part of same company with identical names under same QMS and management. Only difference is that they are situated in two different cities in the same country.
 

Ronen E

Problem Solver
Staff member
Super Moderator
#10
My question is "will it be appropriate if we mention Facility A (the head office) as the manufacturer on the labeling even though the Facility B is the actual manufacturing site!"
In my opinion, yes, it will be appropriate.
When you are being audited make sure to highlight to the auditing entity upfront that the sites are quite far apart; be ready to welcome audit of both sites on the same occasion (maybe different days of the same week); and willing to accept extra charges caused by such separation.
 
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