FDA 483 - Boston IVF at The Women's Hospital - September 09, 2025

Boston IVF Fertility Services at The Women's Hospital, LLC, an HCT/P Reproductive Firm in Newburgh, IN, was cited for two significant observations during an FDA inspection. The firm failed to adequately screen donors for communicable disease agents, specifically Creutzfeldt-Jakob Disease, due to a deficient questionnaire. Additionally, the firm lacked established and maintained procedures for HCT/P donor screening, which did not address critical aspects like identifying relevant communicable diseases or necessary follow-up inquiries.