834037
Alliance Orthopedics, LLC — FEI 3005807344
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 23, 2013
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Tucson, AZ (United States)
Citations
| ID | CFR | Description |
|---|
| 12301 | 21 CFR 1271.150(c)(1)(iii) | Ensurane of compliance |
| 12336 | 21 CFR 1271.180(a) | Procedures to meet core CTGP |
| 12411 | 21 CFR 1271.260(a) | Contamination, mix ups, improper release |
| 12416 | 21 CFR 1271.260(e) | Storage temperatures recorded, maintained |
| 12425 | 21 CFR 1271.265(c)(1) | Release of HCT/Ps by responsible person |
| 12435 | 21 CFR 1271.270(a) | Records maintained concurrently |
| 12437 | 21 CFR 1271.270(a) | Records incomplete |
| 12453 | 21 CFR 1271.290(e) | Documenting disposition of each HCT/P |