483
Westlake IVF, LLCFDA 483 - Westlake IVF, LLC - May 31, 2019
Record Details
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.
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ID · a748dff7-869a-4b6a-97bc-821f732ba47e