FDA Inspection 615803 — Quest Diagnostics
The FDA completed an inspection of Quest Diagnostics on Sep 30, 2009 in Indianapolis, IN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 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 |