FDA 483 - Dallas Forth-Worth Fertility Associates - February 22, 2019

An FDA inspection of James W. Douglas, M.D. dba IVF Plano in Plano, TX, a reproductive HCT/P establishment, revealed two significant observations. The firm failed to adequately screen donors for communicable disease agents, specifically regarding Zika risk factors, and lacked established, defined, and documented procedures for determining donor eligibility.