1024816
SmartSurg Medical Supply LLC — FEI 3011705333
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 11, 2017
- Fiscal Year
- 2017
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Dallas, TX (United States)
Citations
| ID | CFR | Description |
|---|
| 12336 | 21 CFR 1271.180(a) | Procedures to meet core CTGP |
| 12416 | 21 CFR 1271.260(e) | Storage temperatures recorded, maintained |
| 12419 | 21 CFR 1271.265(a) | Evaluation--microorganisms, damage |
| 12443 | 21 CFR 1271.270(d) | Retention time (10 year rules) |