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483
•Kedplasma LLC•January 26, 2023

Kedplasma LLC – FDA 483, Jan 26, 2023

Record Details

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
View Company Profile

ID · bba5ee05-b3a7-48b2-b28a-e1f4b99f8d38

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