Warning letter
Teva Pharmaceutical and Chemical (Hangzhou) Co. Ltd.: warning letter of Apr 5, 2017
FDA warning letter 516381 · Center for Drug Evaluation and Research
Key facts
| Reference number | 516381 |
|---|---|
| Company | Teva Pharmaceutical and Chemical (Hangzhou) Co. Ltd. |
| Subject | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated |
| Issue date | Apr 5, 2017 |
| Posted date | Apr 25, 2017 |
| Issuing office | Center for Drug Evaluation and Research |
| Product type | Drugs |
| Inspection city | Hangzhou |
| Inspection start date | Sep 26, 2016 |
| Letter on fda.gov | fda.gov |
At a glance
- 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: