FDA 483 - Westlake IVF, LLC - May 31, 2019

Westlake IVP, LLC, a reproductive facility in Austin, TX, was cited for multiple deficiencies related to donor screening, eligibility determination, and record-keeping for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). The inspection revealed failures in screening donors for communicable diseases like ZIKA, improper labeling of HCT/Ps, and inaccurate or illegible donor records. These issues indicate significant non-compliance with HCT/P regulations.