1275657
Elite Orthopedics, LLC — FEI 3011803392
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 15, 2025
- Fiscal Year
- 2025
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Columbia, MO (United States)
Citations
| ID | CFR | Description |
|---|
| 12339 | 21 CFR 1271.180(c) | Availability of procedures |
| 12416 | 21 CFR 1271.260(e) | Storage temperatures recorded, maintained |
| 12435 | 21 CFR 1271.270(a) | Records maintained concurrently |
| 12438 | 21 CFR 1271.270(b) | Management system re: core CGTPs |
| 15020 | 21 CFR 1271.200(e) | Documentation of maintenance and cleaning |