FDA 483 - Redicare LLC - March 25, 2022

Redicare llc, a manufacturer of medical devices, was inspected by the FDA and cited for significant deficiencies in its quality system. The firm failed to establish adequate procedures for receiving, reviewing, and evaluating complaints, including investigating complaints for its Body Fluid Cleanup Kit and First Aid Kit and determining the necessity of Medical Device Reports. Additionally, Redicare llc lacked established procedures for corrective and preventive actions.