Warning letter
Lupin Limited [ARCHIVED]: warning letter of May 7, 2009
FDA warning letter 55122 · Center for Drug Evaluation and Research
Key facts
| Reference number | 55122 |
|---|---|
| Company | Lupin Limited [ARCHIVED] |
| Subject | CGMP for Finished Pharmaceuticals/Deviations/Adulterated |
| Issue date | May 7, 2009 |
| Posted date | May 7, 2009 |
| Issuing office | Center for Drug Evaluation and Research |
| Product type | Drugs |
| CFR sections cited | 211.68, 211.192, 211.42(c)(10), 211.56(a), 211.80(d), 211.113(b), 211.180(a), 211.188(b)(11) |
| Inspection city | Mandideep |
| Inspection start date | Oct 31, 2008 |
| 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: