Warning letter
Mylan Pharmaceuticals, Inc.: warning letter of Nov 9, 2018
FDA warning letter 557903 · Center for Drug Evaluation and Research
Key facts
| Reference number | 557903 |
|---|---|
| Company | Mylan Pharmaceuticals, Inc. |
| Subject | Mylan Pharmaceuticals Inc., CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Nov 9, 2018 |
| Posted date | Nov 20, 2018 |
| Issuing office | Center for Drug Evaluation and Research |
| Product type | Drugs |
| CFR sections cited | 211.192, 211.67(a), 211.34, 211.100(b) |
| Inspection city | Morgantown |
| Inspection ZIP | 26505 |
| Inspection start date | Mar 19, 2018 |
| 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: