Warning letter
Mylan Laboratories Limited: warning letter of Aug 6, 2015
FDA warning letter 464863 · Center for Drug Evaluation and Research
Key facts
| Reference number | 464863 |
|---|---|
| Company | Mylan Laboratories Limited |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Aug 6, 2015 |
| Posted date | Aug 17, 2015 |
| Issuing office | Center for Drug Evaluation and Research |
| Product type | Drugs |
| CFR sections cited | 211.42(c)(10)(iv), 211.68(b), 211.113(b), 211.192, 211.160(b) |
| Inspection city | Anekal Taluk, Bangalore |
| Inspection start date | Feb 6, 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: