Warning letter
Vevazz LLC: warning letter of Dec 26, 2019
FDA warning letter 592118 · Office of Medical Device and Radiological Health Operations (Division 3)
Key facts
| Reference number | 592118 |
|---|---|
| Company | Vevazz LLC |
| Subject | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) |
| Issue date | Dec 26, 2019 |
| Posted date | Jan 21, 2020 |
| Issuing office | Office of Medical Device and Radiological Health Operations (Division 3) |
| Product type | Devices |
| CFR sections cited | 820.3(b), 803, 803.17, 807.97, 807.81(a)(3), 807.81(a)(3)(i), 820, 820.3, 807.81(b), 890.9, 890.5500, 890.9(a) |
| Inspection city | Dallas |
| Inspection ZIP | 75204 |
| Inspection start date | Jun 3, 2019 |
| Letter on fda.gov | fda.gov |
At a glance
- 10–99 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: