Warning letter
Teva Parenterals Medicines, Inc. [ARCHIVED]: warning letter of Dec 11, 2009
FDA warning letter 75966 · Los Angeles District Office
Key facts
| Reference number | 75966 |
|---|---|
| Company | Teva Parenterals Medicines, Inc. [ARCHIVED] |
| Subject | CGMP for Finished Pharmaceuticals/Adulterated |
| Issue date | Dec 11, 2009 |
| Posted date | Dec 11, 2009 |
| Issuing office | Los Angeles District Office |
| Product type | Drugs |
| CFR sections cited | 211.22(d), 211.63, 211.192, 211.22(c), 211.42(c)(10)(iv), 211.42(c)(10)(vi), 211.67(a), 211.84(d)(6), 211.113(b), 211.165(b), 211.165(d), 211.67(c) |
| Inspection city | Irvine |
| Inspection ZIP | 92618 |
| Inspection start date | Jul 13, 2009 |
| Letter on fda.gov | web.archive.org |
At a glance
- 10–99 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: