FDA 483 - Aventura Fertility & IVF - March 10, 2022

An FDA inspection of Aventura Fertility & IVF in Aventura, FL, identified significant issues with donor eligibility determination and screening for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). The firm failed to properly document reasons for donor ineligibility, adequately screen donors for communicable disease risks, and establish compliant procedures for donor eligibility. These deficiencies indicate a lack of robust controls over critical aspects of donor screening and record-keeping.