FDA 483 - Center for Assisted Reproduction - September 10, 2025

From September 5 to September 10, 2025, the Food and Drug Administration (FDA) conducted an inspection of the Center for Assisted Reproduction (CARE Fertility) in Bedford, Texas. The inspection focused on the facility’s processes for handling reproductive human tissue. The FDA investigator identified three primary areas of concern regarding donor eligibility and record-keeping. First, the facility failed to document the specific reasons for donor ineligibility in summary records for tissue intended for limited use. This occurred in several instances where donors were flagged due to medical history, physical exams, or disease risk assessments. Second, CARE Fertility did not maintain adequate procedures for managing donor records. Consequently, numerous records were missing essential information, such as confirmation that testing was conducted by certified laboratories and the specific results and interpretations of Hepatitis B virus testing. Third, the facility distributed reproductive tissue from ineligible donors without the required warning labels. Specifically, several units of semen and oocytes were missing a critical statement advising patients of potential communicable disease risks. These observations were issued under the regulatory framework of the Federal Food, Drug, and Cosmetic Act to ensure the safety of human tissue products. While the document does not constitute a final agency determination, CARE Fertility is required to review these observations and submit a formal response. This response should include any objections to the findings or a detailed plan for corrective actions to bring the facility into compliance with federal safety standards.