FDA Inspection 1007009 — Intelligent System Co., Ltd.
The FDA completed an inspection of Intelligent System Co., Ltd. on February 2, 2017 in Nanto. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 2, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Nanto (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 3427 | 21 CFR 820.50(a)(2) | Supplier oversight |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |
| 447 | 21 CFR 820.40 | Lack of procedures, or not maintained |