FDA Inspection 917587 — Blood Bank of Alaska, Inc.
The FDA completed an inspection of Blood Bank of Alaska, Inc. on March 16, 2015 in Anchorage, AK. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 10 citations were issued during this inspection. Product area: Biologics.
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 |