950218
University of Miami Infertility Center — FEI 3005089639
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 2, 2015
- Fiscal Year
- 2016
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Miami, FL (United States)
Citations
| ID | CFR | Description |
|---|
| 12213 | 21 CFR 1271.47(a) | Testing, screening, donor eligibility procedures |
| 12229 | 21 CFR 1271.50(a) | Determination based on screening and testing |
| 12246 | 21 CFR 1271.55(d)(1)(iii) | Documentation--determination, by whom, date |
| 12286 | 21 CFR 1271.80(b) | Specimen collections not timely |
| 12496 | 21 CFR 1271.85(b)(2) | SOP for release; reactive for CMV |