FDA Inspection
RIGHTEYE, LLCRIGHTEYE, LLC – FDA Inspection, Mar 8, 2024
Record Details
This FDA Inspection record concerns RIGHTEYE, LLC, with an inspection on March 8, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 5ea0003c-3bcc-4be4-9673-10f0a4ae251d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1232251
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
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Other FDA inspections of RIGHTEYE, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 8, 2022 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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