FDA Inspection 1205629 — Neitz Instruments Co., Ltd.
The FDA completed an inspection of Neitz Instruments Co., Ltd. on May 19, 2023 in Chiyoda. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 19, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Chiyoda (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 632 | 21 CFR 803.17(a)(2) | Lack of System for Determining MDR Events |