Warning letter
Claris Lifesciences Limited [ARCHIVED]: warning letter of Nov 1, 2010
FDA warning letter 134950 · Center for Drug Evaluation and Research
Key facts
| Reference number | 134950 |
|---|---|
| Company | Claris Lifesciences Limited [ARCHIVED] |
| Subject | CGMP for Finished Pharmaceutical/Unapproved New Drugs/Adulterated |
| Issue date | Nov 1, 2010 |
| Posted date | Nov 1, 2010 |
| Issuing office | Center for Drug Evaluation and Research |
| Product type | Drugs |
| CFR sections cited | 201.115, 211.63, 211.188, 211.192, 310.305, 314.80, 211.67(a), 211.100(a), 211.113(b), 314.81(b)(1), 314.81(b)(1)(ii) |
| Inspection city | Ahmedabad |
| Inspection start date | Jun 5, 2010 |
| Letter on fda.gov | web.archive.org |
At a glance
- 10–99 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: