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

Between September 8 and 9, 2025, the FDA conducted an inspection of Boston IVF Fertility Services at The Women"s Hospital, LLC, in Newburgh, Indiana. The inspection identified two primary violations regarding the facility’s handling of reproductive cells and tissues. First, the firm failed to adequately screen donors of semen and oocytes for risk factors associated with Creutzfeldt-Jakob Disease (CJD). Specifically, the donor medical history questionnaire contained logic flaws that allowed donors to bypass critical questions regarding geographic exposure and travel. This resulted in several instances where fertilized eggs from insufficiently screened donors were transferred to patients or kept in storage. Second, the facility lacked comprehensive written procedures for donor screening. Existing protocols did not specify which communicable diseases required screening, what clinical evidence staff should look for, or how to follow up on relevant medical information. These observations were issued under the regulatory framework of the Federal Food, Drug, and Cosmetic Act concerning Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). To achieve compliance, the firm is required to address these deficiencies by implementing corrective actions and submitting a formal response to the FDA detailing their improvements.