FDA 483 - Almac Pharma Services LLC - December 07, 2017

An FDA inspection of Almac Pharma Services LLC in Audubon, PA, revealed significant deficiencies across multiple areas of their drug repacking and relabeling operations. The firm failed to conduct thorough investigations into product commingling, did not consistently follow quality control procedures for deviations and batch record review, and had inadequately trained personnel. Additionally, the inspection found issues with cleaning validation, maintenance procedures, and the completeness of laboratory records, indicating a need for comprehensive improvements in their quality systems.