FDA Inspection 830721 — Reproductive Medicine Associates of New Jersey LLC
The FDA completed an inspection of Reproductive Medicine Associates of New Jersey LLC on May 8, 2013 in Basking Ridge, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 8, 2013
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Basking Ridge, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12213 | 21 CFR 1271.47(a) | Testing, screening, donor eligibility procedures |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |