FDA Inspection 880297 — Advanced Reproductive Health Centers LTD, Chicago IVF
The FDA completed an inspection of Advanced Reproductive Health Centers LTD, Chicago IVF on May 23, 2014 in Valparaiso, IN. 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). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 23, 2014
- Fiscal Year
- 2014
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Valparaiso, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12223 | 21 CFR 1271.47(b) | Review and approval of procedures |
| 12229 | 21 CFR 1271.50(a) | Determination based on screening and testing |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |