483
Hendrick Regional Laboratory Transfusion ServicesFDA 483 - Hendrick Regional Laboratory Transfusion Services - July 02, 2025
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Record Details
An FDA inspection of Hendrick Regional Laboratory Transfusion Services in Abilene, TX, from June 30 to July 2, 2025, revealed a significant deficiency. The firm failed to maintain complete reports of adverse reactions, specifically regarding an uncompleted investigation into a patient's transfusion reaction. This indicates a lapse in their quality system for tracking and investigating adverse events related to blood products.
- Inspection Date
- July 2, 2025
- Product Type
- Biologics
- Office
- Dallas District Office
- Person
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ID · 9187ffca-2a82-41a0-be80-66f4b93bcfd4