Warning letter
Kim Chemicals Private Ltd.: warning letter of Oct 16, 2017
FDA warning letter 535531 · Center for Drug Evaluation and Research
Key facts
| Reference number | 535531 |
|---|---|
| Company | Kim Chemicals Private Ltd. |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug |
| Issue date | Oct 16, 2017 |
| Posted date | Oct 31, 2017 |
| Issuing office | Center for Drug Evaluation and Research |
| Product type | Drugs |
| CFR sections cited | 201.61, 211.34, 341, 341.20, 347, 211.22(a), 211.165(a), 211.194(a), 341.40(u), 341.74(d)(2)(ii), 347.50(b) |
| Inspection city | Taloja, Raigad |
| Inspection start date | Jun 5, 2017 |
| Letter on fda.gov | fda.gov |
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: