FDA 483 - Center for Reproductive Medicine & Robotic Surgery LLC - October 04, 2019

An FDA inspection of Center for Reproductive Medicine & Robotic Surgery LLC in Saint Louis, MO, revealed significant deficiencies in their reproductive tissue operations. The firm failed to adequately test oocyte donors for communicable diseases like West Nile Virus and Zika Virus. Additionally, the facility did not maintain proper documentation for donor eligibility determinations.