FDA 483 - Fertility Specialists of Texas PLLC. - March 18, 2019

Fertility Specialists of Texas PLLC in Frisco, TX, was inspected and cited for significant deficiencies in their donor screening processes for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). Observations included inadequate screening for communicable disease agents like ZIKA virus due to incomplete donor history questionnaires. Additionally, the firm lacked comprehensive written procedures for physical examinations and determining donor eligibility.