FDA 483 - Impact Fulfillment Services - December 19, 2018
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · 8cdaa07e-5f44-4e1b-9f5c-77ffed12d1df