Warning letter
Claris Injectables Limited: warning letter of Jul 5, 2018
FDA warning letter 543187 · Center for Drug Evaluation and Research
Key facts
| Reference number | 543187 |
|---|---|
| Company | Claris Injectables Limited |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Jul 5, 2018 |
| Posted date | Jul 17, 2018 |
| Issuing office | Center for Drug Evaluation and Research |
| Product type | Drugs |
| CFR sections cited | 211.34, 211.58, 211.188, 211.192 |
| Inspection city | Ahmedabad |
| Inspection start date | Jul 27, 2017 |
| 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: