FDA Inspection 1259483 — KANEKA MEDIX CORPORATION KANAGAWA PLANT
The FDA completed an inspection of KANEKA MEDIX CORPORATION KANAGAWA PLANT on Jan 30, 2025 in Ashigarakami-Gun. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 2 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- No Action Indicated (NAI)
- End Date
- Jan 30, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Ashigarakami-Gun (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |