Hamilton Thorne, Inc – FDA 483, Nov 9, 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.
ID · f097c771-d5f6-4535-82da-851c5ce253ff
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