# FDA 483 - C5 Biomedical LLC - March 02, 2026

Source: https://www.keypedia.com/records/483/c5-biomedical-llc/c567fc9e-4442-41f0-9568-20e109ec73b4

> FDA 483 for C5 Biomedical LLC on March 02, 2026. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: C5 Biomedical LLC
- Inspection Date: 2026-03-02
- Product Type: biologics
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: 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.

## Related Officers

- [Ivan E. Reyes](https://www.keypedia.com/people/ivan-e-reyes/69bac3eb-f63c-45f0-8420-85a7e06b884a)
- [Nerming V. Briones](https://www.keypedia.com/people/nerming-v-briones/b2d9e685-a627-4f9e-854c-0588865fd1b6)

Company: https://www.keypedia.com/companies/c5-biomedical-llc/f66b3d37-079e-48d9-9fad-62ee2cd56c83

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6