Warning letter
Chemspec Chemicals Private Limited: warning letter of Dec 23, 2025
FDA warning letter 718403 · Center for Drug Evaluation and Research (CDER)
Key facts
| Reference number | 718403 |
|---|---|
| Company | Chemspec Chemicals Private Limited |
| Subject | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated |
| Issue date | Dec 23, 2025 |
| Posted date | Jan 13, 2026 |
| Issuing office | Center for Drug Evaluation and Research (CDER) |
| Product type | Drugs |
| Inspection city | Navi Mumbai |
| Inspection start date | Jul 28, 2025 |
| Letter on fda.gov | fda.gov |
At a glance
- 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: