Abbott Molecular, Inc. – FDA 483, Jan 27, 2023

Abbott Molecular, Inc. in Des Plaines, IL, was inspected from January 17-27, 2023, as a medical device manufacturer. The inspection revealed significant issues with the firm's corrective and preventive action (CAPA) procedures and documentation, specifically regarding supplier investigations. The firm failed to adequately establish procedures for effectiveness checks and did not accurately document implementation dates for corrective actions.