FDA 483 - Hamilton Thorne, Inc - November 09, 2023

An FDA inspection of Hamilton Thorne, Inc. in Beverly, MA, from November 6-9, 2023, identified significant deficiencies in the firm's corrective and preventive action (CAPA) procedures. The firm failed to adequately establish and implement procedures for verifying CAPA effectiveness, addressing recurring training-related root causes, and adhering to established due dates for effectiveness checks. These issues indicate a breakdown in the firm's quality system regarding corrective and preventive actions.