Warning letter
Glenmark Pharmaceuticals Limited: warning letter of Oct 3, 2019
FDA warning letter 582701 · Center for Drug Evaluation and Research
Key facts
| Reference number | 582701 |
|---|---|
| Company | Glenmark Pharmaceuticals Limited |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Oct 3, 2019 |
| Posted date | Oct 15, 2019 |
| Issuing office | Center for Drug Evaluation and Research |
| Product type | Drugs |
| CFR sections cited | 211.192 |
| Inspection city | Solan |
| Inspection start date | Apr 15, 2019 |
| Letter on fda.gov | fda.gov |
At a glance
- 1–9 CFR sections cited
- 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: