FDA Inspection 873199 — University Reproductive Associates, P.C.
The FDA completed an inspection of University Reproductive Associates, P.C. on Apr 2, 2014 in Hasbrouck Heights, 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). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 2, 2014
- Fiscal Year
- 2014
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Hasbrouck Heights, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12230 | 21 CFR 1271.50(a) | Responsible person to determine, document |
| 12496 | 21 CFR 1271.85(b)(2) | SOP for release; reactive for CMV |