Hi. Long time creeper
- first time to ask a question.
Is there anywhere in the FDA CFR21 part 820 or ISO 13485 that states how long a company should keep a medical device that has been returned on the basis of a customer complaint before it is destroyed? We typically destroy returned product once the complaint has been resolved (closed) in writing (complete with customer notification) AND until recently, that has worked. Last week, we had a customer call us after 2 weeks of the complaint being closed and asked for the product back but we had destroyed it (a cord for a surgical instrument). The customer told us we had violated FDA protocol... HELP ... what protocol?
Thank you.
Is there anywhere in the FDA CFR21 part 820 or ISO 13485 that states how long a company should keep a medical device that has been returned on the basis of a customer complaint before it is destroyed? We typically destroy returned product once the complaint has been resolved (closed) in writing (complete with customer notification) AND until recently, that has worked. Last week, we had a customer call us after 2 weeks of the complaint being closed and asked for the product back but we had destroyed it (a cord for a surgical instrument). The customer told us we had violated FDA protocol... HELP ... what protocol?


