Warning letter
Anicare Pharmaceuticals Pvt Ltd.: warning letter of Feb 28, 2019
FDA warning letter 569251 · Center for Drug Evaluation and Research
Key facts
| Reference number | 569251 |
|---|---|
| Company | Anicare Pharmaceuticals Pvt Ltd. |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated/Misbranded |
| Issue date | Feb 28, 2019 |
| Posted date | Mar 19, 2019 |
| Issuing office | Center for Drug Evaluation and Research |
| Product type | Drugs |
| CFR sections cited | 201.128, 201.15, 201.61, 211.34, 330.1, 201.66(b)(2), 211.67(b), 211.100(a), 211.166(a) |
| Inspection city | Navi Mumbai |
| Inspection start date | Jul 30, 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: