FDA Inspection 1180091 — The New York Fertility Center
The FDA completed an inspection of The New York Fertility Center on September 23, 2022 in Flushing, 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
- September 23, 2022
- Fiscal Year
- 2022
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Flushing, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12221 | 21 CFR 1271.47(a) | Procedures for all other requirements |
| 12254 | 21 CFR 1271.60(b) | Identified as quarantined, distinguishable |
| 12493 | 21 CFR 1271.90(c) | Eligibility not required--warning labels |