UCSF Radiopharmaceutical FacilityJuly 24, 2025

FDA 483 - UCSF Radiopharmaceutical Facility - July 24, 2025

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Record Details

The FDA inspected UCSF Radiopharmaceutical Facility in San Francisco, CA, a PET drug manufacturer, and found significant deficiencies. Observations included failures in sterility testing, inadequate production and process controls for sterile PET drugs, and non-adherence to quality assurance procedures. These issues raise concerns about the quality and purity of released sterile PET drug products.

Company: UCSF Radiopharmaceutical Facility
Inspection Date: July 24, 2025
Product Type: Drugs
Office: San Francisco District Office
People: Gloria E. Andia
Andrew Le (Regulatory Affairs Specialist)
Khoa Nathan V. Tran (issuing_officer)

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ID · 4e3397c7-28d5-4dc9-8c60-ced9dc662298