FDA 483 - RMA Long Island IVF - March 01, 2022

An FDA inspection of RMA Long Island IVF in Melville, NY, revealed deficiencies in determining HCT/P donor eligibility. The firm failed to adequately screen oocyte donors for Zika virus risk factors and accepted donations from a donor with an incomplete risk factor questionnaire. These issues indicate a failure to ensure donor suitability prior to donation.