709036
Precision Spine Inc — FEI 3005739886
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 1, 2011
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Pearl, MS (United States)
Citations
| ID | CFR | Description |
|---|
| 12336 | 21 CFR 1271.180(a) | Procedures to meet core CTGP |
| 12421 | 21 CFR 1271.265(a) | Acceptance criteria designed to prevent CD |
| 12432 | 21 CFR 1271.265(e) | Documentation elements for activities |
| 12433 | 21 CFR 1271.265(f) | Return to inventory--procedures |
| 12447 | 21 CFR 1271.290(b) | Establishing a system |
| 12457 | 21 CFR 1271.320(a) | Procedures re complaints |