FDA 483 - Westlake IVF, LLC - April 01, 2021

Westlake IVF, LLC, a reproductive facility in Austin, TX, was cited for significant deficiencies in donor screening, eligibility determination, and record-keeping practices for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). Repeat observations highlight issues with incomplete donor screening questionnaires, inadequate physical examinations, and improper labeling of HCT/Ps from ineligible donors. The firm also failed to maintain complete records of communicable disease testing and lacked adequate procedures for donor eligibility.