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483
•Vitalant•December 17, 2021

Vitalant – FDA 483, Dec 17, 2021

Record Details

An FDA inspection of Vitalant, a blood bank in Granite Bay, CA, revealed a significant deficiency in record-keeping practices. The firm failed to adequately document donor travel and residence history during screening for malaria risk factors. This lapse in detailed record-keeping could compromise the complete history of work performed to ensure blood product safety.

Company
Vitalant
Inspection date
December 17, 2021
Product type
biologics
Office
Division of Human and Animal Food Operations - West V
Person
  • Shelley H. Beausoleil
View Company Profile

ID · 10f6f77c-7e31-4ded-8c06-3b55f90f8c9c

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