# FDA 483 - KEDPLASMA LLC - June 26, 2023

Source: https://www.keypedia.com/records/483/kedplasma-llc/8af511db-5ee4-4cb6-a40a-cc45637d2908

> FDA 483 for KEDPLASMA LLC on June 26, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: KEDPLASMA LLC
- Inspection Date: 2023-06-26
- Product Type: biologics
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: KEDPLASMA LLC in Sanford, FL, was inspected by the FDA from June 22-26, 2023. The inspection revealed a significant issue where the responsible physician failed to review and sign accumulated laboratory data, specifically serum protein electrophoresis (SPE) results, within the required 14 days. This lapse led to subsequent plasma donations being collected from donors whose previous failed SPE results were not properly approved by the responsible physician.

## Related Officers

- [Investigator at U.S.FDA](https://www.keypedia.com/people/barbara-t-carmichael/4c451805-e327-450d-b2e5-48a40f6232fe)
- [Lura Baquero](https://www.keypedia.com/people/lura-baquero/55dc6eb5-01d5-427e-a3ef-cc6ca35f3837)

Company: https://www.keypedia.com/companies/kedplasma-llc/9409dc0e-db2b-4df7-89dd-6bc2e2289d9f

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