Warning letter
Turbare Manufacturing: warning letter of Sep 16, 2025
FDA warning letter 713516 · Center for Drug Evaluation and Research (CDER)
Key facts
| Reference number | 713516 |
|---|---|
| Company | Turbare Manufacturing |
| Subject | Compounding Pharmacy/Adulterated Drug Products |
| Issue date | Sep 16, 2025 |
| Posted date | Dec 2, 2025 |
| Issuing office | Center for Drug Evaluation and Research (CDER) |
| Product type | Drugs |
| CFR sections cited | 210.1(b), 211.42(c)(10)(iv), 211.113(b), 211.192, 200.10(b), 211.165(d) |
| Inspection city | Conway |
| Inspection ZIP | 72032 |
| Inspection start date | Jan 14, 2025 |
| Letter on fda.gov | fda.gov |
At a glance
- 1–9 CFR sections cited
- OAI Linked inspection classification
- Yes Form FDA 483 issued
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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: