Warning letter
Enprani Co., Ltd.: warning letter of Aug 15, 2019
FDA warning letter 580548 · Center for Drug Evaluation and Research
Key facts
| Reference number | 580548 |
|---|---|
| Company | Enprani Co., Ltd. |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated/Failure to Register |
| Issue date | Aug 15, 2019 |
| Posted date | Sep 10, 2019 |
| Issuing office | Center for Drug Evaluation and Research |
| Product type | Drugs |
| CFR sections cited | 211.100(a), 211.68(b), 201.15, 211.22(a), 211.34, 211.166(a), 201.128, 201.66, 211.165(a) |
| Inspection city | Jung |
| Inspection start date | Mar 11, 2019 |
| 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: