FDA Inspection 578213 — NYU Langone Reproductive Specialists Of New York
The FDA completed an inspection of NYU Langone Reproductive Specialists Of New York on Apr 21, 2009 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
- Apr 21, 2009
- Fiscal Year
- 2009
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Mineola, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12221 | 21 CFR 1271.47(a) | Procedures for all other requirements |
| 12247 | 21 CFR 1271.55(d)(2) | Accurate, indelible, legible |