FDA Inspection 1218928 — Iridex Corporation
The FDA completed an inspection of Iridex Corporation on September 20, 2023 in Mountain View, CA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- September 20, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Mountain View, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 740 | 21 CFR 803.52(a)(3) | Patient Gender |
| 774 | 21 CFR 803.52(e)(4) | Date Received by Manufacturer |