FDA Inspection 1268429 — Louisville Reproductive Center
The FDA completed an inspection of Louisville Reproductive Center on April 28, 2025 in Louisville, KY. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 28, 2025
- Fiscal Year
- 2025
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Louisville, KY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12252 | 21 CFR 1271.60(a) | Completion of eligibility determination |
| 12490 | 21 CFR 1271.85(b)(1) | Cell-associated CD |
| 12492 | 21 CFR 1271.85(a) | Infection with communicable disease agents |