681455
University of Louisville Physicians OBGYN & Womens Health Fertility Center — FEI 3004557180
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 13, 2010
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Louisville, KY (United States)
Citations
| ID | CFR | Description |
|---|
| 12221 | 21 CFR 1271.47(a) | Procedures for all other requirements |
| 12223 | 21 CFR 1271.47(b) | Review and approval of procedures |
| 12230 | 21 CFR 1271.50(a) | Responsible person to determine, document |
| 12282 | 21 CFR 1271.75(d) | Donors with risks not determined ineligible |
| 12283 | 21 CFR 1271.75(e) | Abbreviated procedure |
| 12290 | 21 CFR 1271.80(d)(1) | Reactive tests--not determined ineligible |
| 12337 | 21 CFR 1271.180(a) | Design adequate to bar spread of CD's |