FDA Inspection 718197 — Advanced Fertility Group, PC
The FDA completed an inspection of Advanced Fertility Group, PC on April 13, 2011 in Evansville, IN. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 13, 2011
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Evansville, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12222 | 21 CFR 1271.47(a) | Design of procedures to ensure compliance |
| 12223 | 21 CFR 1271.47(b) | Review and approval of procedures |
| 12229 | 21 CFR 1271.50(a) | Determination based on screening and testing |
| 12492 | 21 CFR 1271.85(a) | Infection with communicable disease agents |
| 12494 | 21 CFR 1271.85(c) | Reproductive cells or tissues |
| 15025 | 21 CFR 1271.85(b)(2) | Cytomegalovirus (CMV) |
| 15026 | 21 CFR 1271.85(c) | Reproductive cells or tissues-cell-associated CD |