FDA 483 - Center for Reproductive Medicine & Robotic Surgery LLC - March 11, 2024

The Center for Reproductive Medicine & Robotic Surgery LLC in Saint Louis, MO, received a Form 483 for two significant observations during an FDA inspection. The firm failed to adequately screen oocyte donors for numerous communicable disease risk factors, including Zika virus, using an insufficient medical history questionnaire. Additionally, the facility lacked a standard operating procedure for the release of HCT/Ps from donors who test reactive for cytomegalovirus.