Warning letter
Barox Co., Ltd.: warning letter of Nov 28, 2018
FDA warning letter 565314 · Center for Drug Evaluation and Research
Key facts
| Reference number | 565314 |
|---|---|
| Company | Barox Co., Ltd. |
| Subject | Barox Co., Ltd., CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Nov 28, 2018 |
| Posted date | Dec 4, 2018 |
| Issuing office | Center for Drug Evaluation and Research |
| Product type | Drugs |
| CFR sections cited | 211, 211.125(a), 211.22(d), 211.142, 211.34 |
| Inspection city | Jungwon, Seongnam |
| Inspection start date | May 17, 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: