FDA Inspection 963211 — Aurora Optics Company Inc.
The FDA completed an inspection of Aurora Optics Company Inc. on February 10, 2016 in College Point, NY. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- February 10, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- College Point, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3269 | 21 CFR 820.80(b) | Incoming acceptance records, documentation |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |