Jessica,
While this is a good practice, there is no specific requirement for expired products, either for a shelf life or expiration date, these must be returned to the legal manufacturer. There is a requirement these must be dispositioned in an appropriate manner. Technically if these are at your distributor and a financial transaction has occurred, those products are now owned by the distributor. This is where the manufacturer and distributor agreement would take over. Distributors should then have their own processes and procedures defined for handling and disposition of expired materials. It is very common from a cGMP, FDA QSR, and ISO 13485, i.e. Section 7.5.11 of ISO 13485 for preservation of product, perspective in a manufacturer's warehouse that material is checked on a routine basis for expired materials or short-sale materials. If materials are expired usually there is a procedure established how these materials are removed and disposed or maybe handled through the Nonconforming Product procedure. If these materials are at a distributor, i.e. out of the manufacturer's direct control, then these distributors should have a similar process. Whether you get back the product or not is up to stipulations made in the agreement or the agreement could specify the distributor must dispose of those materials with documented records. The cost of getting product back especially from international locations may be prohibitive from having everything returned to the manufacturer.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 09-Jul-2019 20:22
From: Jessica Staub
Subject: Expired Product Retrival
Dear RAPs community -
Are medical device manufacturers obligated to retrieve expired implants from the field? I'm currently working with an organization that would request the return of expired implants from their stocking distributors each month, with decent success. However, as the organization grows, they are finding it more and more difficult to retrieve this inventory from the field. While this process has value to the organization, are they obligated to request expired inventory from their distribitors?
Thank you,
Jessica
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Jessica Staub
Thorndale PA
United States
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