Warning letter
ELITech Group B.V.: warning letter of Sep 20, 2017
FDA warning letter 534429 · Center for Devices and Radiological Health
Key facts
| Reference number | 534429 |
|---|---|
| Company | ELITech Group B.V. |
| Subject | CGMP/QSR/Medical Devices/Adulterated/Misbranded |
| Issue date | Sep 20, 2017 |
| Posted date | Oct 24, 2017 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 803.17, 803.50(a), 820, 803, 803.3, 806.10, 806 |
| Inspection city | Spankeren |
| Inspection start date | Mar 27, 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: