Warning letter
Mylan Laboratories Limited, (Nashik FDF): warning letter of Apr 3, 2017
FDA warning letter 517906 · Center for Drug Evaluation and Research
Key facts
| Reference number | 517906 |
|---|---|
| Company | Mylan Laboratories Limited, (Nashik FDF) |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Apr 3, 2017 |
| Posted date | Apr 11, 2017 |
| Issuing office | Center for Drug Evaluation and Research |
| Product type | Drugs |
| CFR sections cited | 211.192, 211.22(a) |
| Inspection city | Nashik |
| Inspection start date | Sep 5, 2016 |
| 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: