FDA Inspection 568479 — Community Blood Center Of Greater Kansas City
The FDA completed an inspection of Community Blood Center Of Greater Kansas City on February 5, 2009 in Kansas City, MO. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 8 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- February 5, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Kansas City, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 154 | 21 CFR 606.160(a)(1) | Concurrent documentation |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 9225 | 21 CFR 606.171 | Biological product deviation report |
| 9238 | 21 CFR 630.40(b)(3) | Results of testing |
| 9266 | 21 CFR 610.40(e) | Further testing |