FDA Inspection 1227528 — CBR Systems Inc
The FDA completed an inspection of CBR Systems Inc on Jan 17, 2024 in Tucson, AZ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 17, 2024
- Fiscal Year
- 2024
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Tucson, AZ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12329 | 21 CFR 1271.160(d) | Documentation/approval prior to implementation |
| 12356 | 21 CFR 1271.195(a) | Adequate control, proper conditions |
| 12375 | 21 CFR 1271.210(a) | Use prior to verification |
| 12407 | 21 CFR 1271.250(b) | Verification of label accuracy, legibility, integrity |
| 12429 | 21 CFR 1271.265(d) | Shipping conditions appropriate |