Warning letter
Medibo N.V. [ARCHIVED]: warning letter of Oct 2, 2009
FDA warning letter 69823 · Center for Devices and Radiological Health
Key facts
| Reference number | 69823 |
|---|---|
| Company | Medibo N.V. [ARCHIVED] |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Oct 2, 2009 |
| Posted date | Oct 2, 2009 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 803.18, 803.50, 803.50(a)(2), 820, 803 |
| Inspection city | Hamont-Achel |
| Inspection start date | Jan 19, 2009 |
| 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: