FDA 483 - Surgical Instrument Manufacturers, LLC - February 22, 2024

Surgical Instrument Manufacturers, LLC in Fenton, MO, was cited during an FDA inspection from February 20-22, 2024, for significant deficiencies in its corrective and preventive action (CAPA) procedures. The firm failed to adequately establish and document CAPA processes, specifically regarding root cause determination, verification of effectiveness, and implementation records for actions taken in response to complaints of mislabeled medical devices.