FDA 483 - Impact Fulfillment Services - December 19, 2018

An FDA inspection of Impact Fulfillment Services, a drug repacker in Burlington, NC, revealed significant deficiencies across multiple areas. Observations included incomplete batch production records, unsanitary warehouse conditions with spider infestations and inadequate cleaning records, and failure to maintain required record retention for rejected materials. Additionally, the firm did not follow its own customer complaint procedures, failed to identify rejected products in quarantine, and lacked proper quality unit review and approval for equipment calibration.