Warning letter
Apotex Research Private Limited: warning letter of Jan 30, 2015
FDA warning letter 437669 · Center for Drug Evaluation and Research
Key facts
| Reference number | 437669 |
|---|---|
| Company | Apotex Research Private Limited |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Jan 30, 2015 |
| Posted date | Feb 2, 2015 |
| Issuing office | Center for Drug Evaluation and Research |
| Product type | Drugs |
| CFR sections cited | 211.192, 211.22(d), 211.68(b), 211.113(a), 211.194(a) |
| Inspection city | Bengaluru |
| Inspection start date | Jun 23, 2014 |
| 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: