FDA 483 - Verichem Laboratories, Inc. - May 24, 2022

An FDA inspection of Verichem Laboratories, Inc. in Providence, RI, revealed significant deficiencies across its quality management system. The firm failed to adequately establish procedures for reporting field corrections, evaluating suppliers, managing acceptance activities, calibrating equipment, controlling design changes, and handling customer complaints. These observations indicate a need for comprehensive improvements to ensure compliance with regulatory requirements.