FDA Inspection 1260820 — KANEKA MEDICAL VIETNAM Co.,Ltd.
The FDA completed an inspection of KANEKA MEDICAL VIETNAM Co.,Ltd. on Feb 13, 2025 in Thuan An. 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). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 13, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Thuan An (Vietnam)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3262 | 21 CFR 820.250(a) | Statistical techniques - Lack of or inadequate procedures |
| 537 | 21 CFR 820.70(a) | Production processes |