FDA 483 - Aspire Fertility Institute Dallas - July 12, 2023

An FDA inspection of Aspire Fertility Institute Dallas, a reproductive HCT/P establishment in Addison, TX, revealed two significant observations. The facility failed to ensure that summaries of records for HCT/Ps included statements confirming communicable disease testing was performed by CLIA-certified laboratories. Additionally, donor eligibility screening documents were found to be incomplete, lacking critical information for assessing donor risk.