Warning letter
Intas Pharmaceuticals Limited: warning letter of Jul 28, 2023
FDA warning letter 652067 · Center for Drug Evaluation and Research | CDER
Key facts
| Reference number | 652067 |
|---|---|
| Company | Intas Pharmaceuticals Limited |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Jul 28, 2023 |
| Posted date | Aug 1, 2023 |
| Issuing office | Center for Drug Evaluation and Research | CDER |
| Product type | Drugs |
| CFR sections cited | 211.100(a), 211.22, 211.160(a), 211.194(a), 211.165(e) |
| Inspection city | Sanand |
| Inspection start date | Nov 22, 2022 |
| 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: