Warning letter
Safrel Pharmaceuticals LLC: warning letter of Aug 7, 2026
FDA warning letter 730520 · Center for Drug Evaluation and Research (CDER)
Key facts
| Reference number | 730520 |
|---|---|
| Company | Safrel Pharmaceuticals LLC |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Aug 7, 2026 |
| Posted date | Aug 18, 2026 |
| Issuing office | Center for Drug Evaluation and Research (CDER) |
| Product type | Food/Cosmetics |
| CFR sections cited | 211.34, 211.22(a), 211.22(d), 211.42 |
| Inspection city | Dayton |
| Inspection ZIP | 08810 |
| Inspection start date | Jan 13, 2026 |
| 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: