FDA Inspection 785859 — CBR Systems Inc
The FDA completed an inspection of CBR Systems Inc on Jun 14, 2012 in Tucson, AZ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 14, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Tucson, AZ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12320 | 21 CFR 1271.160(b)(3) | Actions verified, short and long term solutions |
| 12399 | 21 CFR 1271.230(a) | Process validation procedures |