FDA Inspection 755348 — Community Blood Center Of Greater Kansas City
The FDA completed an inspection of Community Blood Center Of Greater Kansas City on Nov 4, 2011 in Kansas City, MO. 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). 3 citations were issued during this inspection. Product area: Biologics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 4, 2011
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Kansas City, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 154 | 21 CFR 606.160(a)(1) | Concurrent documentation |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 83 | 21 CFR 606.100(b)(4) | Relate products to the donor |