FDA 483 - Brown Fertility Associates, PA - September 25, 2024

An FDA inspection of Brown Fertility Associates, PA in Jacksonville, FL, a human reproductive tissue/fertility clinic, revealed two significant observations. The firm failed to prominently label HCT/Ps with appropriate warning statements when donor eligibility determinations were not required, specifically for donations later used with gestational carriers. Additionally, the summary of records for HCT/Ps did not include a complete listing and interpretation of all communicable disease test results performed on donors.