FDA 483 - Medicraft, Inc. - November 27, 2024

Medicraft, Inc., a contract manufacturer of Class I and II medical devices in Elmwood Park, NJ, was cited for significant deficiencies in its quality system. The inspection revealed inadequate procedures for process validation, monitoring, equipment maintenance, incoming product acceptance, calibration, corrective and preventive actions, and product identification throughout various stages of manufacturing. These issues indicate a lack of robust controls to ensure product quality and compliance.