Warning letter
Sandoz Private Limited: warning letter of Oct 22, 2015
FDA warning letter 445532 · Center for Drug Evaluation and Research
Key facts
| Reference number | 445532 |
|---|---|
| Company | Sandoz Private Limited |
| Subject | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated |
| Issue date | Oct 22, 2015 |
| Posted date | Nov 23, 2015 |
| Issuing office | Center for Drug Evaluation and Research |
| Product type | Drugs |
| CFR sections cited | 211.68(b), 211.182, 211.192, 211.25(a), 211.42(c)(10)(iv), 211.188(b), 211.113(b) |
| Inspection city | Navi Mumbai |
| Inspection start date | Aug 12, 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: