Product Recall Procedures

Product Recall Procedures. The Manufacturer shall maintain a documented product recall procedure that can be initiated within twenty-four (24) hours of a recall decision. The recall procedure shall include: (a) a designated recall coordinator with authority to initiate and manage recall activities; (b) a communication plan for notifying the Client, regulatory authorities, distributors, and affected customers; (c) a traceability system capable of identifying all affected lot numbers, distribution channels, and customer shipments within four (4) hours; (d) procedures for segregation, quarantine, return, and disposition of recalled product; (e) a root cause investigation process to determine the cause of the recall and prevent recurrence; (f) a mock recall exercise conducted at least annually to verify the effectiveness of the recall system; and (g) documentation and retention of all recall records for a minimum period as required by applicable regulations. The Manufacturer shall bear all costs associated with a recall caused by its failure to comply with Specifications, cGMP requirements, or the terms of this Agreement.