FDA 483 - The Reproductive Medicine Group, LLC - July 12, 2019

The FDA issued a Form 483 to The Reproductive Medicine Group, P.A. in Temple Terrace, FL, following an inspection of their reproductive tissue establishment. Observations included determining HCT/P donor eligibility prior to receiving complete communicable disease test results and deeming a donor eligible despite residing in an area with active Zika transmission. These findings indicate deficiencies in donor screening and eligibility determination processes.