Warning letter
International Medical Development Corporation: warning letter of Sep 17, 2015
FDA warning letter 456906 · Denver District Office
Key facts
| Reference number | 456906 |
|---|---|
| Company | International Medical Development Corporation |
| Subject | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) |
| Issue date | Sep 17, 2015 |
| Posted date | Oct 6, 2015 |
| Issuing office | Denver District Office |
| Product type | Devices |
| CFR sections cited | 820.40, 807.81(a)(3)(ii), 820, 807.81(b) |
| Inspection city | Huntsville |
| Inspection ZIP | 84317 |
| Inspection start date | Mar 16, 2015 |
| Letter on fda.gov | web.archive.org |
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: