FDA 483 - IVF Laboratory of Central Florida LLC - December 11, 2019

An FDA inspection of A&M Endeavors, LLC, a reproductive tissue establishment in Winter Park, FL, revealed significant deficiencies in donor screening and record-keeping practices. The firm failed to adequately screen semen donors for communicable disease risk factors, maintain complete summaries of communicable disease test results, and establish required procedures for donor eligibility determination and HCT/P labeling. These issues indicate a lack of robust controls to ensure donor safety and product quality.