FDA Inspection 1242818 — North Hudson IVF Center For Fertility & Gynecology P.C.
The FDA completed an inspection of North Hudson IVF Center For Fertility & Gynecology P.C. on Jul 2, 2024 in Englewood Cliffs, NJ. 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). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 2, 2024
- Fiscal Year
- 2024
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Englewood Cliffs, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12213 | 21 CFR 1271.47(a) | Testing, screening, donor eligibility procedures |
| 12239 | 21 CFR 1271.55(b)(2) | Listing and interpretation of CD tests performed |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |