FDA Inspection 873201 — 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 Apr 3, 2014 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
- Apr 3, 2014
- Fiscal Year
- 2014
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Englewood Cliffs, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12230 | 21 CFR 1271.50(a) | Responsible person to determine, document |
| 12279 | 21 CFR 1271.75(b) | Risk factors, leukocyte-rich cells or tissues |
| 12280 | 21 CFR 1271.75(c) | Reproductive cells/ tissues- general |