C5 Biomedical LLCMarch 2, 2026

FDA 483 - C5 Biomedical LLC - March 02, 2026

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Record Details

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.

Company: C5 Biomedical LLC
Inspection Date: March 2, 2026
Product Type: Biologics
Office: Office of Medical Device and Radiological Health Division II
People: Ivan E. Reyes
Nerming V. Briones

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ID · c567fc9e-4442-41f0-9568-20e109ec73b4