FDA Inspection 574101 — A&D Company Manufacturing, Ltd.
The FDA completed an inspection of A&D Company Manufacturing, Ltd. on Feb 19, 2009 in Shimotsuma. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Feb 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 |