VitalantJune 19, 2019

FDA 483 - Vitalant - June 19, 2019

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Record Details

An FDA inspection of Vitalant, a blood bank and donor collection center in Lafayette, LA, identified a failure to maintain quality control records. Specifically, the firm lacked documentation of antigen typing quality control results for specific antigens on multiple dates. This indicates a deficiency in record-keeping practices for critical quality control procedures.

Company: Vitalant
Inspection Date: June 19, 2019
Product Type: Biologics
Office: New Orleans District Office
Person: Richard J. Bashay

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ID · a1911bf5-5fda-4eb2-bf44-f4d815e5319c