677589
Inova Health Care Services — FEI 1177788
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 25, 2010
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Sterling, VA (United States)
Citations
| ID | CFR | Description |
|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 12203 | 21 CFR 606.170(a) | Adverse Reaction- Reports of Investigations |
| 15030 | 21 CFR 606.60(b) | Equipment calibration frequency |
| 154 | 21 CFR 606.160(a)(1) | Concurrent documentation |
| 155 | 21 CFR 606.160(b) | Required records |
| 160 | 21 CFR 606.160(a)(1) | Person performing, test results, interpretation |
| 165 | 21 CFR 606.170(a) | Adverse reaction - Maintenance of Reports |
| 41 | 21 CFR 606.40(a)(1) | Provide space for examination |
| 57 | 21 CFR 606.60(a) | Maintain and clean equipment |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |