FDA Inspection 752438 — Center For Advanced Reproductive Medicine & Fertility
The FDA completed an inspection of Center For Advanced Reproductive Medicine & Fertility on October 27, 2011 in Edison, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 27, 2011
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Edison, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12221 | 21 CFR 1271.47(a) | Procedures for all other requirements |
| 12223 | 21 CFR 1271.47(b) | Review and approval of procedures |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |
| 12287 | 21 CFR 1271.80(c) | Kits not FDA approved, specifically labeled |
| 12492 | 21 CFR 1271.85(a) | Infection with communicable disease agents |