The New York Fertility CenterSeptember 23, 2022

FDA 483 - The New York Fertility Center - September 23, 2022

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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.

Company: The New York Fertility Center
Inspection Date: September 23, 2022
Product Type: Biologics
Office: Division of Human and Animal Food Operations - East I
Person: Amy W. Yan-Mai

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ID · 2a00a347-89f4-479a-831e-350868ad4777