FDA 483 - IVFMD - Advanced Reproductive Laboratory - June 04, 2019

IVFMD - Advanced Reproductive Laboratory in Irving, TX, was inspected for human reproductive tissue practices and received a Form 483 with three observations. The firm failed to adequately screen oocyte donors for Zika virus and transferred tissues without counseling recipients. Additionally, the facility did not adhere to its own SOP for handling CMV IgG positive semen, transferring it to CMV negative or unknown status recipients without counseling. Finally, donor identifying information was included in records accompanying HCT/Ps.