FDA Inspection 1240299 — Nikkiso Vietnam MFG Co., Ltd.
The FDA completed an inspection of Nikkiso Vietnam MFG Co., Ltd. on May 23, 2024 in Buu Cuc Trung Tam Thanh Pho Ho Chi Minh. 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
- May 23, 2024
- Fiscal Year
- 2024
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Buu Cuc Trung Tam Thanh Pho Ho Chi Minh (Vietnam)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |