# FDA 483 - UCSF Radiopharmaceutical Facility - July 24, 2020

Source: https://www.keypedia.com/records/483/ucsf-radiopharmaceutical-facility/dc9cd92b-a2f8-4d06-b777-ca7e2d40ce3f

> FDA 483 for UCSF Radiopharmaceutical Facility on July 24, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: UCSF Radiopharmaceutical Facility
- Inspection Date: 2020-07-24
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: UCSF Radiopharmaceutical Facility in San Francisco, a PET Manufacturer, received a Form 483 with seven observations related to significant deficiencies in quality control, manufacturing processes, and laboratory procedures. Key issues include failure to investigate out-of-specification results, inadequate change control, unvalidated analytical methods, and insufficient stability testing programs. These findings indicate a lack of robust systems to ensure the quality, purity, and identity of their PET drug products.

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- [SVP Consulting & Operations](https://www.keypedia.com/people/linda-f-murphy/a8b9737f-d5f4-4a36-8684-2fb050d008f2)
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Company: https://www.keypedia.com/companies/ucsf-radiopharmaceutical-facility/9b56691c-8dc6-401f-96f5-64ae8c45891f

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b