615803
Quest Diagnostics — FEI 1872752
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 30, 2009
- Fiscal Year
- 2009
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Indianapolis, IN (United States)
Citations
| ID | CFR | Description |
|---|
| 31 | 21 CFR 606.20(b) | Qualifications of responsible personnel |
| 65 | 21 CFR 606.65(c) | Testing of representative samples of reagent lots |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 91 | 21 CFR 606.100(b)(12) | Criteria for suitability of reissue of returned blood |
| 9225 | 21 CFR 606.171 | Biological product deviation report |