Warning letter
Somerset Therapeutics Private Limited: warning letter of Sep 4, 2025
FDA warning letter 711340 · Center for Drug Evaluation and Research (CDER)
Key facts
| Reference number | 711340 |
|---|---|
| Company | Somerset Therapeutics Private Limited |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Sep 4, 2025 |
| Posted date | Sep 16, 2025 |
| Issuing office | Center for Drug Evaluation and Research (CDER) |
| Product type | Drugs |
| CFR sections cited | 314.81(b)(1)(ii), 314.81(b)(1), 211.42(c)(10)(vi), 211.113(b), 211.192 |
| Inspection city | Bengaluru |
| Inspection start date | Feb 10, 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: