Warning letter
AQUAVIT PHARMACEUTICALS INC: warning letter of Jun 17, 2021
FDA warning letter 607150 · Office of Medical Device and Radiological Health Division 1 – East
Key facts
| Reference number | 607150 |
|---|---|
| Company | AQUAVIT PHARMACEUTICALS INC |
| Subject | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) |
| Issue date | Jun 17, 2021 |
| Posted date | Jun 29, 2021 |
| Issuing office | Office of Medical Device and Radiological Health Division 1 – East |
| Product type | Devices |
| CFR sections cited | 807.81(b), 878.4430, 878.4800, 4, 3.2(e) |
| Country | 1 |
| Letter on fda.gov | fda.gov |
At a glance
- 1–9 CFR sections cited
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: