FDA 483 - Green Valley Fertility Partners - April 13, 2022

Fisch LTD d.b.a Green Valley Fertility Partners received a Form 483 for failing to properly label Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) from ineligible donors. Specifically, an oocyte from a donor who tested positive for chlamydia was not labeled with required biohazard and communicable disease risk warnings before being transferred to a recipient. This indicates a serious lapse in donor eligibility and product labeling procedures, posing potential health risks.