FDA Inspection 1193351 — Northern California Community Blood Bank
The FDA completed an inspection of Northern California Community Blood Bank on December 16, 2022 in Eureka, CA. 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
- December 16, 2022
- Fiscal Year
- 2023
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Eureka, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 18038 | 21 CFR 606.100(b) | SOPs for investigations, records |
| 35 | 21 CFR 606.40 | Clean & orderly |
| 67 | 21 CFR 606.65(e) | Following manufacturer's instructions |
| 78 | 21 CFR 606.100(c) | Record review prior to release |
| 98 | 21 CFR 606.100(c) | Thorough investigations |