Warning letter
Emcure Pharmaceuticals Limited: warning letter of Mar 3, 2016
FDA warning letter 455201 · Center for Drug Evaluation and Research
Key facts
| Reference number | 455201 |
|---|---|
| Company | Emcure Pharmaceuticals Limited |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Mar 3, 2016 |
| Posted date | Mar 15, 2016 |
| Issuing office | Center for Drug Evaluation and Research |
| Product type | Drugs |
| CFR sections cited | 211.113(b), 211.160(b), 211.194(a) |
| Inspection city | Pune |
| Inspection start date | Jan 27, 2015 |
| Letter on fda.gov | web.archive.org |
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: