FDA Inspection 584441 — CBR Systems Inc
The FDA completed an inspection of CBR Systems Inc on Jun 3, 2009 in Tucson, AZ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 3, 2009
- Fiscal Year
- 2009
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Tucson, AZ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12279 | 21 CFR 1271.75(b) | Risk factors, leukocyte-rich cells or tissues |
| 12364 | 21 CFR 1271.195(c) | Monitoring-microorganisms where appropriate |
| 12387 | 21 CFR 1271.220(a) | Causing contamination, increasing risks |
| 12398 | 21 CFR 1271.230(a) | Validation & approval--established procedures |