Warning letter
D.O.R.C. Intl. B.V.: warning letter of Sep 1, 2015
FDA warning letter 453349 · Center for Devices and Radiological Health
Key facts
| Reference number | 453349 |
|---|---|
| Company | D.O.R.C. Intl. B.V. |
| Subject | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) |
| Issue date | Sep 1, 2015 |
| Posted date | Dec 22, 2015 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 807.81(a)(3)(i), 807.81(b) |
| Inspection city | Zuidland |
| Inspection start date | Sep 8, 2014 |
| Letter on fda.gov | web.archive.org |
At a glance
- 1–9 CFR sections cited
- NAI 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: