FDA Inspection 1199081 — Zhang Medical P.C. d/b/a New Hope Fertility Center
The FDA completed an inspection of Zhang Medical P.C. d/b/a New Hope Fertility Center on March 3, 2023 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). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 3, 2023
- Fiscal Year
- 2023
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- New York, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12230 | 21 CFR 1271.50(a) | Responsible person to determine, document |
| 12252 | 21 CFR 1271.60(a) | Completion of eligibility determination |
| 12493 | 21 CFR 1271.90(c) | Eligibility not required--warning labels |