FDA Inspection 1276699 — UCSF Radiopharmaceutical Facility
The FDA completed an inspection of UCSF Radiopharmaceutical Facility on July 24, 2025 in San Francisco, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 24, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- San Francisco, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 17764 | 21 CFR 212.20(e) | Written QA procedures established, followed |
| 17812 | 21 CFR 212.50 | Adequate controls (general) |
| 17813 | 21 CFR 212.50(a) | Written control procedures |
| 17877 | 21 CFR 212.70(c) | Conform to specs prior to release |