Warning letter
UCSF Radiopharmaceutical Facility: warning letter of Apr 13, 2026
FDA warning letter 719568 · Center for Drug Evaluation and Research (CDER)
Key facts
| Reference number | 719568 |
|---|---|
| Company | UCSF Radiopharmaceutical Facility |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Apr 13, 2026 |
| Posted date | Apr 21, 2026 |
| Issuing office | Center for Drug Evaluation and Research (CDER) |
| Product type | Drugs |
| CFR sections cited | 314.81(b)(1), 314.81(b)(1)(ii) |
| Inspection city | San Francisco |
| Inspection ZIP | 94107 |
| Inspection start date | Jul 21, 2025 |
| Letter on fda.gov | fda.gov |
At a glance
- 1–9 CFR sections cited
- OAI Linked inspection classification
- Yes Form FDA 483 issued
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA warning letters
FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.
Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date: