FDA Inspection 1097178 — Columbia University Fertility Center
The FDA completed an inspection of Columbia University Fertility Center on July 23, 2019 in New York, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 23, 2019
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- New York, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12231 | 21 CFR 1271.50(b)(1) | Donor screening standards |