FDA Inspection 947868 — NYU Langone Reproductive Specialists Of New York
The FDA completed an inspection of NYU Langone Reproductive Specialists Of New York on Oct 16, 2015 in Mineola, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 16, 2015
- Fiscal Year
- 2016
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Mineola, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12222 | 21 CFR 1271.47(a) | Design of procedures to ensure compliance |
| 12282 | 21 CFR 1271.75(d) | Donors with risks not determined ineligible |