FDA EIR - Almac Clinical Services, LLC. - June 08, 2016

An FDA inspection of Almac Clinical Services, LLC., located in Durham, NC, was conducted from June 6-8, 2016. The inspection, requested by CDER as part of the FY16 work plan, focused on compliance with Current Good Manufacturing Practices (cGMP) under CPGM 7356.002B for Drug Repackers and Relabelers, specifically examining the Quality, Materials, and Production Systems. During this inspection, no Form FDA 483, Inspectional Observations, was issued. However, a single verbal observation was noted regarding inaccurate quantity documentation for two items in the Pre-receipt Logbook, although the official inventory system contained the correct data. Management acknowledged this discrepancy and committed to implementing appropriate preventative actions to address future occurrences. The report also confirmed that all observations from the previous inspection on April 17, 2012, classified as Voluntary Action Indicated, had been satisfactorily addressed. These included updating technical agreements for returned products, clarifying reconciliation report procedures for deviations, and revising written procedures for employee gowning and label storage. The overall outcome of the 2016 inspection indicated compliance with regulatory standards, with immediate management agreement on the single minor observation.