FDA Inspection 1075190 — Genesis Fertility & Reproductive Medicine
The FDA completed an inspection of Genesis Fertility & Reproductive Medicine on December 21, 2018 in Brooklyn, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 21, 2018
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Brooklyn, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12213 | 21 CFR 1271.47(a) | Testing, screening, donor eligibility procedures |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |
| 12282 | 21 CFR 1271.75(d) | Donors with risks not determined ineligible |