FDA Inspection 1129967 — NYU Langone Reproductive Specialists of New York
The FDA completed an inspection of NYU Langone Reproductive Specialists of New York on September 25, 2020 in Mineola, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 25, 2020
- Fiscal Year
- 2020
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Mineola, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12229 | 21 CFR 1271.50(a) | Determination based on screening and testing |
| 12286 | 21 CFR 1271.80(b) | Specimen collections not timely |