Warning letter
RightEye, LLC: warning letter of Dec 20, 2022
FDA warning letter 643192 · Division of Medical Device and Radiological Health Operations East
Key facts
| Reference number | 643192 |
|---|---|
| Company | RightEye, LLC |
| Subject | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device |
| Issue date | Dec 20, 2022 |
| Posted date | Jan 31, 2023 |
| Issuing office | Division of Medical Device and Radiological Health Operations East |
| Product type | Devices |
| CFR sections cited | 803, 830, 830.3, 807.81(a)(3)(ii), 830.300(a), 820, 882.1460 |
| Inspection city | Bethesda |
| Inspection ZIP | 20817 |
| Inspection start date | Jun 28, 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: