Kedplasma LLCJanuary 26, 2023

FDA 483 - Kedplasma LLC - January 26, 2023

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An FDA inspection of BFL Plasma, Inc. in Phoenix, AZ, from January 24-26, 2023, revealed a significant failure in determining donor suitability. Specifically, the firm allowed at least two donors to donate blood components despite incomplete health assessments, indicating a lapse in proper screening procedures and record-keeping.

Company: Kedplasma LLC
Inspection Date: January 26, 2023
Product Type: Biologics
Office: Division of Pharmaceutical Quality Operations IV
Person: Emily S. McGann

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