Louisville Reproductive Center

Warning LetterOpen

Dr. Miriam S. Krause Medical Director Louisville Reproductive Center 4123 Dutchmans Lane, Suite 416 Louisville , KY 40207-4733 United States Mkrause@ivfkentucky.comFEI 3005081370Issued Jan 23, 2026Center for Biologics Evaluation and Research

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3005081370.

Violations6

Issue DateJan 23, 2026

Product TypeBiologics

StatusOpen

Letter Details

Firm: Louisville Reproductive Center
Location: Dr. Miriam S. Krause Medical Director Louisville Reproductive Center 4123 Dutchmans Lane, Suite 416 Louisville , KY 40207-4733 United States Mkrause@ivfkentucky.com
FEI Number: 3005081370
Country: United States
Issue Date: January 23, 2026
Issuing Office: Center for Biologics Evaluation and Research
Product Type: Biologics
Status: Open

Summary

Louisville Reproductive Center, a biologics facility specializing in human cells and tissues for reproductive use, failed to conduct required infectious disease testing on directed semen donors in violation of 21 CFR 1271.85. Specifically, the facility did not test donors for critical communicable disease agents including HIV-1, hepatitis B and C, West Nile Virus, and HTLV-I/II before determining donors eligible and releasing their specimens for use. These violations were identified during an FDA inspection conducted in April 2025 at the facility's Louisville, Kentucky location.

Louisville Reproductive Center FDA Warning Letter, January 23, 2026