FDA Inspection 1200617 — Sakura Seiki Co., Ltd. Chikuma Factory
The FDA completed an inspection of Sakura Seiki Co., Ltd. Chikuma Factory on March 24, 2023 in Chikuma. 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
- March 24, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Chikuma (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |
| 632 | 21 CFR 803.17(a)(2) | Lack of System for Determining MDR Events |
| 812 | 21 CFR 803.56 | Submission of Supplement to Individual Report Within One Month |