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Zhang Medical P.C. dba New Hope Fertility Center, a fertility clinic in New York, failed to comply with FDA regulations governing human cells, tissues, and cellular products (HCT/Ps) during a November 2021 inspection. The facility's critical violations included failure to determine oocyte donors as ineligible despite documented risk factors for communicable diseases, specifically multiple instances where donors with Zika virus exposure or travel history to high-risk areas were incorrectly cleared for donation. These deviations violated 21 CFR Part 1271, which establishes mandatory donor screening and eligibility determinations required under the Public Health Service Act.