876330
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 22, 2014
- Fiscal Year
- 2014
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Apo (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 4425 | 21 CFR 606.60(a) | Equipment observed, standardized, calibrated |
| 77 | 21 CFR 606.100(b) | Written SOPs available for use by personnel |
| 94 | 21 CFR 606.100(b)(15) | Schedules and procedures for equipment & calibration |