Warning letter
WAVi Co.: warning letter of Oct 20, 2023
FDA warning letter 658549 · Division of Medical Device and Radiological Health Operations West
Key facts
| Reference number | 658549 |
|---|---|
| Company | WAVi Co. |
| Subject | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device |
| Issue date | Oct 20, 2023 |
| Posted date | Oct 31, 2023 |
| Issuing office | Division of Medical Device and Radiological Health Operations West |
| Product type | Devices |
| CFR sections cited | 812, 807.81(a)(1), 820 |
| Inspection city | Denver |
| Inspection ZIP | 80205 |
| Inspection start date | Mar 23, 2023 |
| 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: