FDA Inspection 1015641 — Yokowo Co Ltd
The FDA completed an inspection of Yokowo Co Ltd on Apr 13, 2017 in Tomioka. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 7 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 13, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Tomioka (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 2557 | 21 CFR 820.30(c) | Design input - documentation |
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3201 | 21 CFR 820.40(a) | Not approved or obsolete document retrieval |
| 3676 | 21 CFR 820.30(f) | Design verification - documentation |
| 3696 | 21 CFR 820.100(b) | Documentation |