FDA Inspection 1083806 — Blood Bank of Alaska, Inc.
The FDA completed an inspection of Blood Bank of Alaska, Inc. on March 22, 2019 in Anchorage, AK. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 22, 2019
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Anchorage, AK (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 238 | 21 CFR 640.11(a) | General requirements - storage |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |