574101
A&D Company Manufacturing, Ltd. — FEI 3006899423
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- February 19, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Shimotsuma (Japan)
Citations
| ID | CFR | Description |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3191 | 21 CFR 820.30(g) | Design validation - production units |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |
| 4070 | 21 CFR 820.30(g) | Design validation - documentation |