FDA Inspection 1049359 — Neo Dental Chemical Products Co., Ltd.
The FDA completed an inspection of Neo Dental Chemical Products Co., Ltd. on Mar 27, 2018 in Shibuya. 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). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 27, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Shibuya (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |