483
The New York Fertility CenterThe New York Fertility Center – FDA 483, Sep 23, 2022
Record Details
The New York Fertility Center in Flushing, NY, was cited for multiple deficiencies related to its handling of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). The firm failed to properly label HCT/Ps from donors with incomplete eligibility determinations and did not clearly identify quarantined HCT/Ps. Additionally, the center lacked adequate written procedures for the storage and limited use of products from ineligible donors.
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ID · 2a00a347-89f4-479a-831e-350868ad4777
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