Warning letter
Dexcowin Co. Ltd.: warning letter of Feb 20, 2018
FDA warning letter 545388 · Center for Devices and Radiological Health
Key facts
| Reference number | 545388 |
|---|---|
| Company | Dexcowin Co. Ltd. |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Feb 20, 2018 |
| Posted date | Mar 13, 2018 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 1002.30(a)(2), 820, 803, 803.17, 820.40, 1010, 1002.20(a) |
| Inspection city | Geumcheon |
| Inspection start date | Aug 28, 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: