1081380
Virginia Center for Reproductive Medicine — FEI 3003939253
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 25, 2019
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Reston, VA (United States)
Citations
| ID | CFR | Description |
|---|
| 12221 | 21 CFR 1271.47(a) | Procedures for all other requirements |
| 12229 | 21 CFR 1271.50(a) | Determination based on screening and testing |
| 12239 | 21 CFR 1271.55(b)(2) | Listing and interpretation of CD tests performed |
| 12246 | 21 CFR 1271.55(d)(1)(iii) | Documentation--determination, by whom, date |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |
| 12282 | 21 CFR 1271.75(d) | Donors with risks not determined ineligible |
| 12286 | 21 CFR 1271.80(b) | Specimen collections not timely |