Warning letter
DigiMed Corp: warning letter of Nov 8, 2016
FDA warning letter 509750
Key facts
| Reference number | 509750 |
|---|---|
| Company | DigiMed Corp |
| Subject | Medical Device Reporting/Misbranded |
| Issue date | Nov 8, 2016 |
| Posted date | Nov 22, 2016 |
| Product type | Devices |
| CFR sections cited | 803, 803.3, 803.17, 820, 803.50(a) |
| Inspection city | Seoul |
| Inspection start date | Jul 24, 2016 |
| Letter on fda.gov | web.archive.org |
At a glance
- 1–9 CFR sections cited
- 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: