927844
FUJIFILM Healthcare Manufacturing Corporation Hitachiomiya Office — FEI 3010516924
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- April 20, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Hitachiomiya (Japan)
Citations
| ID | CFR | Description |
|---|
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 3120 | 21 CFR 820.80(a) | Lack of or inadequate procedures - Acceptance activities |
| 3236 | 21 CFR 820.72(b) | Calibration procedures - content |
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |