FDA Inspection 819345 — North Jersey Fertility LLC
The FDA completed an inspection of North Jersey Fertility LLC on Feb 20, 2013 in Oradell, 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). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 20, 2013
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Oradell, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12229 | 21 CFR 1271.50(a) | Determination based on screening and testing |
| 12231 | 21 CFR 1271.50(b)(1) | Donor screening standards |
| 12232 | 21 CFR 1271.50(b)(2) | Donor testing not negative for CD agents |
| 12237 | 21 CFR 1271.55(a)(3) | Summary--records used to make determination |