FDA Inspection 574101 — A&D Company Manufacturing, Ltd.
The FDA completed an inspection of A&D Company Manufacturing, Ltd. on February 19, 2009 in Shimotsuma. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 19, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: 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 |