FDA 483 - Louisville Reproductive Center - April 08, 2021

The FDA inspection of Louisville Reproductive Center identified critical failures in donor screening and eligibility determination for human cells, tissues, and cellular and tissue-based products (HCT/Ps). The firm failed to properly screen donors for communicable diseases, including determining ineligibility for reactive donors and conducting complete screenings. Significant deficiencies were also noted in donor record-keeping and the establishment of adequate testing procedures.