FDA 483 - Fangyinmeng MD Inc. - October 22, 2021

Fangyinmeng MD Inc., a human reproductive tissue establishment in Irvine, CA, received a Form 483 citing two significant observations during an FDA inspection. The firm failed to adequately screen semen and oocyte donors for communicable disease agents, including West Nile Virus, and did not ensure all directed oocyte donors received required physical examinations. Additionally, donor eligibility procedures and standard operating procedures were not properly reviewed, approved, and dated by a responsible person before implementation, with some SOP titles not matching their content.