Warning letter
Alseal: warning letter of Nov 10, 2016
FDA warning letter 507073 · Center for Devices and Radiological Health
Key facts
| Reference number | 507073 |
|---|---|
| Company | Alseal |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Nov 10, 2016 |
| Posted date | Nov 10, 2016 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 806.20, 7.40, 803, 806, 806.10, 803.50(a)(2) |
| Inspection city | Besancon |
| Inspection start date | Jun 6, 2016 |
| 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: