FDA 483 - C5 Biomedical LLC - March 02, 2026

C5 Biomedical LLC, a human tissue establishment in Boca Raton, FL, was inspected by the FDA from 2/24/2026 to 3/2/2026. The inspection revealed a significant concern regarding inadequate environmental controls for cleaning and disinfecting rooms and equipment. Specifically, the firm failed to check the effectiveness of disinfectants used in aseptic processing areas, posing a potential risk to product sterility.