Warning letter
Louisville Reproductive Center: warning letter of Jan 23, 2026
FDA warning letter 722350 · Center for Biologics Evaluation and Research
Key facts
| Reference number | 722350 |
|---|---|
| Company | Louisville Reproductive Center |
| Subject | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
| Issue date | Jan 23, 2026 |
| Posted date | Feb 10, 2026 |
| Issuing office | Center for Biologics Evaluation and Research |
| Product type | Biologics |
| CFR sections cited | 1271, 1271.45, 1271.47(a), 1271.60(a), 1271.75(a)(1), 1271.85(a), 1271.85(b)(1), 1271.90(b), 1271.90(c), 1271.155 |
| Inspection city | Louisville |
| Inspection ZIP | 40207 |
| Inspection start date | Apr 23, 2025 |
| Letter on fda.gov | fda.gov |
At a glance
- 10–99 CFR sections cited
- OAI Linked inspection classification
- Yes Form FDA 483 issued
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA warning letters
FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.
Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date: