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?
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?