FDA Inspection 1260082 — Kaneka Corporation
The FDA completed an inspection of Kaneka Corporation on February 6, 2025 in Settsu. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 6, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Settsu (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 3173 | 21 CFR 820.198(d) | Evaluation, timeliness, identification |
| 3262 | 21 CFR 820.250(a) | Statistical techniques - Lack of or inadequate procedures |