Warning letter
Pratik Doshi, M.D. / Alembic Pharmaceuticals Ltd.: warning letter of Jul 10, 2026
FDA warning letter 731020 · Center for Drug Evaluation and Research (CDER)
Key facts
| Reference number | 731020 |
|---|---|
| Company | Pratik Doshi, M.D. / Alembic Pharmaceuticals Ltd. |
| Subject | In Vivo Bioavailability-Bioequivalence Studies – Clinical |
| Issue date | Jul 10, 2026 |
| Posted date | Jul 21, 2026 |
| Issuing office | Center for Drug Evaluation and Research (CDER) |
| Product type | Drugs |
| CFR sections cited | 50, 50.3, 50.20, 50.22, 50.25(a)(1), 312, 312.3, 312.60, 320.31(c) |
| Inspection city | Vadodara |
| Inspection start date | Mar 3, 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: