FDA 483 - Repromed Fertility Center - November 22, 2019

An FDA inspection of Repromed Fertility Center in Dallas, TX, from November 4-22, 2019, identified significant deficiencies in their screening and testing procedures for egg donors. The firm failed to adequately screen donors for communicable disease risk factors, specifically regarding Zika virus, and did not test two directed egg donors for West Nile Virus. These issues indicate a failure to ensure donor eligibility and product safety.