FDA Inspection 776334 — Blood Bank of Alaska, Inc.
The FDA completed an inspection of Blood Bank of Alaska, Inc. on March 28, 2012 in Anchorage, AK. 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) (VAI)
- End Date
- March 28, 2012
- Fiscal Year
- 2012
- 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 |
| 41 | 21 CFR 606.40(a)(1) | Provide space for examination |
| 78 | 21 CFR 606.100(c) | Record review prior to release |
| 9239 | 21 CFR 630.40(b)(4) | Follow up and counseling |
| 98 | 21 CFR 606.100(c) | Thorough investigations |