FDA 483 - Montgomery Fertility Center - January 21, 2020

An FDA inspection of Montgomery Women's Medical Center PC dba Montgomery Fertility Center in Rockville, MD, a reproductive human tissue establishment, revealed significant deficiencies in donor eligibility determination processes. The firm failed to adequately screen and test anonymous oocyte donors for communicable disease agents like West Nile Virus and Zika, and lacked proper procedures and documentation for donor eligibility. These issues indicate a serious lack of control over critical aspects of HCT/P donor management.