1265875
New Directions Fertility Center — FEI 3011885945
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 2, 2025
- Fiscal Year
- 2025
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Gilbert, AZ (United States)
Citations
| ID | CFR | Description |
|---|
| 12213 | 21 CFR 1271.47(a) | Testing, screening, donor eligibility procedures |
| 12224 | 21 CFR 1271.47(c) | Availability of procedures |
| 12229 | 21 CFR 1271.50(a) | Determination based on screening and testing |
| 12238 | 21 CFR 1271.55(b)(1) | Statement re: certified testing lab |
| 12239 | 21 CFR 1271.55(b)(2) | Listing and interpretation of CD tests performed |
| 12241 | 21 CFR 1271.55(b)(4) | Reasons for ineligibility on summary |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |
| 12286 | 21 CFR 1271.80(b) | Specimen collections not timely |