FDA Inspection 837531 — Reproductive Center Of Central New Jersey
The FDA completed an inspection of Reproductive Center Of Central New Jersey on June 24, 2013 in S Plainfield, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 24, 2013
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- S Plainfield, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12236 | 21 CFR 1271.55(a)(2) | Eligibility statement--basis of determination |
| 12237 | 21 CFR 1271.55(a)(3) | Summary--records used to make determination |
| 12270 | 21 CFR 1271.65(a) | Improper release prevention--storage, I.D. |