FDA 483 - IVF Laboratory of Central Florida LLC - July 14, 2021

A&M Endeavors, LLC, a reproductive tissue establishment in Winter Park, FL, was cited for significant deficiencies in donor screening and eligibility determination processes. The inspection revealed failures to adequately screen donors for communicable diseases, properly document donor eligibility, and maintain complete records of communicable disease test results. Additionally, the firm lacked established procedures for donor testing and screening, with some issues being repeat observations from a previous inspection.