FDA 483 - KCI POLYMEDICS BV - December 11, 2025

KCI Polymedics BV in Peer, Belgium, was inspected and cited for significant deficiencies in its manufacturing processes for Class II sterile V.A.C. Whitefoam devices. The firm failed to adequately validate critical cleaning, polymerization, and acid pressing processes, and also lacked proper documentation of process parameters for sealers. These issues are serious as they relate to product quality and have been linked to customer complaints including foul odor, injury, and infection.