FDA 483 - Veterans Affairs Palo Alto Health Care System - February 13, 2025
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An FDA inspection of Veterans Affairs Palo Alto Health Care System's Hospital Transfusion Service in Livermore, CA, revealed significant deficiencies in equipment management. The firm failed to regularly observe and calibrate equipment used in compatibility testing, storage, and distribution of blood and blood components, including centrifuges and refrigerators. These failures indicate a lack of adherence to established standard operating procedures for critical laboratory equipment.
- Inspection Date
- February 13, 2025
- Product Type
- Biologics
- Person
ID · 66db2c49-b445-44de-bf3c-c4da34d9f532