710743
Airon Corporation — FEI 3003697063
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- February 17, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Melbourne, FL (United States)
Citations
| ID | CFR | Description |
|---|
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 3837 | 21 CFR 820.25(b) | Training records |
| 486 | 21 CFR 820.50(a) | Evaluation of suppliers, contractors, etc., requirements |