FDA Inspection 1234274 — Aeye Health Inc.

Aeye Health Inc. — FEI 3025301728

The FDA completed an inspection of Aeye Health Inc. on March 15, 2024 in New York, NY. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 1 citation was issued during this inspection. Product area: Devices.

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
March 15, 2024
Fiscal Year
2024
Product Type
Devices
Project Area
Compliance: Devices
Location
New York, NY (United States)

Citations

IDCFRDescription
63021 CFR 803.17Lack of Written MDR Procedures