FDA Inspection 1253060 — Houchin Community Blood Bank
The FDA completed an inspection of Houchin Community Blood Bank on Oct 30, 2024 in Bakersfield, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 30, 2024
- Fiscal Year
- 2025
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Bakersfield, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 18134 | 21 CFR 640.21(g) | Informed consent |
| 224 | 21 CFR 640.4(f) | Arm preparation |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 9288 | 21 CFR 640.21(a) | Eligibility of platelet donors |