Warning letter
Lupin Limited: warning letter of Sep 10, 2019
FDA warning letter 572345 · Center for Drug Evaluation and Research
Key facts
| Reference number | 572345 |
|---|---|
| Company | Lupin Limited |
| Subject | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated |
| Issue date | Sep 10, 2019 |
| Posted date | Oct 1, 2019 |
| Issuing office | Center for Drug Evaluation and Research |
| Product type | Drugs |
| CFR sections cited | 211.100(a), 211.192, 211.67(a) |
| Inspection city | Mandideep |
| Inspection start date | Nov 26, 2018 |
| Letter on fda.gov | fda.gov |
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: