Customer Complaints & Service Calls - FDA Requirements

sagai

Quite Involved in Discussions
#11
but customer complaint reaches the Manufacturer, not its supplier. ?
My understanding that supplier actually can not receive customer complaint (except some very special case, like during customer visit), because of the definition of customer complaint, moreover even the supplier receives, the supplier shall register it not itsown, but the Manufacturer's complaint register.
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Sz.
 
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M

MIREGMGR

#12
If a company in the product chain needs complaint data, that company is regulatorily obligated to contracturally require their associates...customers, distributors, etc....to share that data with the concerned company, and to have equal requirements in their contracts so that such data flows all the way up the chain in a timely manner from all of the end users.
 

sagai

Quite Involved in Discussions
#13
I would need this, sorry for hanging on it.

So, the supplier has to have customer complaint procedure for complaint may come against the finished medical device conformity regardless the supplier does not market that finished medical device?
 
M

MIREGMGR

#14
I should have said, above, "If a regulatorily responsible company in the product chain (...)"

A contract manufacturer of a product that becomes a device doesn't need to track complaints, repairs, etc., unless they are a contract manufacturer for that product but also a registered device maker for other products.

In that latter case, the FDA has held in recent years that such a contract manufacturer/device maker is obligated to have an effective compliance stance on such issues in the particular case where (in the FDA's analysis) they should have known that their customer for contract manufactured products was not regulatorily compliant, and their device-maker activities should make them knowledgable as to the requirements.
 
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