FDA 483 - Links Medical Products Inc - October 18, 2023

An FDA inspection of Links Medical Products Inc, a manufacturer in Laguna Hills, CA, identified significant deficiencies in its corrective and preventive action (CAPA) procedures. The firm failed to adequately establish and follow its CAPA process, resulting in numerous overdue and unverified CAPAs. This indicates a breakdown in the quality system for addressing and preventing issues.