FDA 483 - Steinleitner, Alex, MD, Inc - June 26, 2025

An FDA inspection of Steinleitner, Alex, MD, Inc. in San Luis Obispo, CA, a reproductive medicine establishment, revealed significant deficiencies in donor screening and eligibility determination processes. The firm failed to adequately screen oocyte and semen donors for communicable disease risk factors and lacked proper procedures for donor eligibility. Additionally, donor eligibility records were incomplete, missing critical establishment address information.