FDA 483 - Dallas-Fort Worth Fertility Associates, P.A. - December 09, 2019

Dallas-Fort Worth Fertility Associates, P.A. in Dallas was inspected by the FDA, revealing a critical issue in their donor eligibility process. The firm was cited for determining an HCT/P donor eligible before receiving all required relevant communicable disease agent testing results. This practice indicates a failure to ensure donor safety and compliance with regulatory standards.