FDA 483 - Island Reproductive Services - January 26, 2023

Island Reproductive Services in Staten Island, NY, was cited for significant deficiencies in its human reproductive tissue program, specifically concerning oocyte donor screening and eligibility. The firm failed to adequately screen donors for communicable diseases and risk factors, prematurely determined donor eligibility before test results were available, and maintained inadequate standard operating procedures and inaccurate donor eligibility records. These issues indicate a systemic failure to ensure donor safety and compliance with regulatory requirements.