FDA 483 - Almac Pharma Services LLC - August 22, 2025

An FDA inspection of Almac Pharma Services LLC, a drug repacker/relabeler in Audubon, PA, revealed significant deficiencies in quality control unit procedures and material management. Observations included failures to complete Out of Specification (OOS) investigations timely, improper water system qualification, inadequate control of rejected materials, and non-adherence to procedures for receiving drug product containers. Additionally, the firm failed to provide required retraining to all personnel involved in a rejected batch investigation, highlighting systemic issues in quality oversight and compliance.