Warning letter
Hikal Limited: warning letter of Aug 20, 2025
FDA warning letter 709370 · Center for Drug Evaluation and Research (CDER)
Key facts
| Reference number | 709370 |
|---|---|
| Company | Hikal Limited |
| Subject | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated |
| Issue date | Aug 20, 2025 |
| Posted date | Sep 9, 2025 |
| Issuing office | Center for Drug Evaluation and Research (CDER) |
| Product type | Drugs |
| Inspection city | Jigani |
| Inspection start date | Feb 3, 2025 |
| Letter on fda.gov | fda.gov |
At a glance
- 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: