483
C5 Biomedical LLCC5 Biomedical LLC – FDA 483, Mar 2, 2026
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.
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ID · c567fc9e-4442-41f0-9568-20e109ec73b4
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