FDA Inspection 959460 — Yale Center For Reproductive Medicine & Infertility
The FDA completed an inspection of Yale Center For Reproductive Medicine & Infertility on February 19, 2016 in Orange, CT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 19, 2016
- Fiscal Year
- 2016
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Orange, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12213 | 21 CFR 1271.47(a) | Testing, screening, donor eligibility procedures |
| 12223 | 21 CFR 1271.47(b) | Review and approval of procedures |
| 12246 | 21 CFR 1271.55(d)(1)(iii) | Documentation--determination, by whom, date |
| 12247 | 21 CFR 1271.55(d)(2) | Accurate, indelible, legible |
| 12282 | 21 CFR 1271.75(d) | Donors with risks not determined ineligible |
| 12496 | 21 CFR 1271.85(b)(2) | SOP for release; reactive for CMV |