917587
Blood Bank of Alaska, Inc. — FEI 3071403
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 16, 2015
- Fiscal Year
- 2015
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Anchorage, AK (United States)
Citations
| ID | CFR | Description |
|---|
| 12202 | 21 CFR 606.170(a) | Adverse Reaction - Investigations |
| 143 | 21 CFR 606.140(b) | Provisions to monitor lab test procedures & instruments |
| 154 | 21 CFR 606.160(a)(1) | Concurrent documentation |
| 281 | 21 CFR 640.34(g)(2) | Final product - evidence of thawing |
| 41 | 21 CFR 606.40(a)(1) | Provide space for examination |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 9234 | 21 CFR 630.40(c) | Notification w/in 8 weeks |
| 9239 | 21 CFR 630.40(b)(4) | Follow up and counseling |
| 9328 | 21 CFR 610.1 | Consideration of all results |
| 98 | 21 CFR 606.100(c) | Thorough investigations |