Warning letter
ZYTO Technologies, Inc.: warning letter of Jun 21, 2023
FDA warning letter 652316 · Division of Medical Device and Radiological Health Operations West
Key facts
| Reference number | 652316 |
|---|---|
| Company | ZYTO Technologies, Inc. |
| Subject | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device |
| Issue date | Jun 21, 2023 |
| Posted date | Jul 11, 2023 |
| Issuing office | Division of Medical Device and Radiological Health Operations West |
| Product type | Devices |
| CFR sections cited | 803, 820, 820.3, 820.3(b), 882.1540, 807.81(b), 882.9(a) |
| Inspection city | Pleasant Grove |
| Inspection ZIP | 84062 |
| Inspection start date | Dec 5, 2022 |
| 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: