FDA 483 - Dallas IVF - December 09, 2019

An FDA inspection of Dallas IVF, a facility handling reproductive tissues in Frisco, TX, revealed significant deviations from established procedures and record-keeping requirements. The firm failed to follow its SOP for releasing HCT/Ps from CMV-positive donors, transferring semen to recipients whose CMV status was unknown without proper testing or counseling. Additionally, records for donor eligibility were incomplete, lacking signatures and dates, making it impossible to track who performed the work.