682680
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 24, 2010
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- La Quinta, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12203 | 21 CFR 606.170(a) | Adverse Reaction- Reports of Investigations |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |