Warning letter
Unetixs Vascular, Inc.: warning letter of Feb 4, 2020
FDA warning letter 598016 · Office of Medical Device and Radiological Health Operations (Division 1)
Key facts
| Reference number | 598016 |
|---|---|
| Company | Unetixs Vascular, Inc. |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Feb 4, 2020 |
| Posted date | Feb 25, 2020 |
| Issuing office | Office of Medical Device and Radiological Health Operations (Division 1) |
| Product type | Devices |
| CFR sections cited | 820 |
| Inspection city | Warwick |
| Inspection ZIP | 02886 |
| Inspection start date | Sep 17, 2019 |
| 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: