Does FDA Registration QSR need to cover non-medical devices for contract repackager?

#1
We are a contract packaging company that packages industrial goods. We are currently not ISO Certified or FDA Registered.

We were contacted to package a Class II Medical Device. We would down pack bulk goods of the device into the smaller final packaging where it will we be sent back to our customer for distribution.

We understand that we would need to register with the FDA as a re-packager of Finished Devices and follow the regulations that it entails, (QSR, cGMP, ETC....).

The question that we have is would the QSR criteria need to cover the non medical device repackaging that we do? Or can we isolate the packaging of this device in a section of our facility and handle it separately from the industrial good? Would we get audited for all of the different items that we package or would it be just the items that are associated to medical device? Some of the criteria do overlap (receiving, warehouse management, and shipping), but we do not go into as much detail for the industrial good items as we would need to for the medical device.

Thank you.
 
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Ajit Basrur

Staff member
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#2
The non-medical would not be in the scope as the QSR relates to "medical devices" or finished medical devices alone. Try to bifurcate this quality system and make it all inclusive so that the other aspects of the non-medical systems do not come up in the scope. In some of the previous companies where I worked, we had consumer&electronics, automotive and medical and I had put this sort of an all-inclusive quality system and did not pivot on other non-medical systems.

Btw, what are your customer thoughts?
 
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