FDA 483 - Key Surgical LLC - July 18, 2022

Key Surgical LLC, a device manufacturer in Eden Prairie, MN, was inspected and cited for deficiencies in its corrective and preventive action (CAPA) procedures. The firm failed to adequately establish and follow procedures for verifying CAPA effectiveness, closing CAPAs before full implementation of corrective actions, and managing new complaints related to closed CAPAs. The inspection revealed issues with sponge degradation in their Anti-Fog and Electro Lube products, where the firm's CAPA process was found to be non-compliant with its own established procedures.