Warning letter
Sun Pharmaceutical Industries Inc [ARCHIVED]: warning letter of Aug 25, 2010
FDA warning letter 113749 · New Jersey District Office
Key facts
| Reference number | 113749 |
|---|---|
| Company | Sun Pharmaceutical Industries Inc [ARCHIVED] |
| Subject | CGMP for Finished Pharmaceuticals/Adulterated |
| Issue date | Aug 25, 2010 |
| Posted date | Aug 25, 2010 |
| Issuing office | New Jersey District Office |
| Product type | Drugs |
| CFR sections cited | 314.81(b)(1)(ii), 211.192, 211.22(d), 211.100(a), 211.115(a), 211.115(b), 211.130(e), 314.81 |
| Inspection city | Princeton |
| Inspection ZIP | 08540 |
| Inspection start date | Feb 25, 2010 |
| 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: