FDA 483 - Pharmasol Corporation - June 14, 2021

During an FDA inspection from June 7-14, 2021, Pharmasol Corporation, a human drug contract manufacturer in Stoughton, MA, received one observation. The observation noted a failure to properly inspect and release components, specifically actuators, by the quality control unit prior to their use in drug product manufacturing. This indicates a significant lapse in the firm's quality control procedures for incoming materials.