FDA Inspection 873468 — Airways Development LLC
The FDA completed an inspection of Airways Development LLC on April 9, 2014 in Kenilworth, NJ. 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
- April 9, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Kenilworth, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2630 | 21 CFR 820.30(e) | Design review - documentation |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |