KEDPLASMA LLCJune 26, 2023

FDA 483 - KEDPLASMA LLC - June 26, 2023

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Record Details

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.

Company: KEDPLASMA LLC
Inspection Date: June 26, 2023
Product Type: Biologics
Office: Office of Medical Device and Radiological Health Division II
People: Barbara T. Carmichael (Investigator at U.S.FDA)
Lura Baquero

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ID · 8af511db-5ee4-4cb6-a40a-cc45637d2908