Chelsea Fertility NYCNovember 22, 2024

FDA 483 - Chelsea Fertility NYC - November 22, 2024

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Record Details

Chelsea Fertility NYC, a reproductive human tissue establishment in New York, was inspected by the FDA from November 18-22, 2024. The inspection revealed significant deficiencies in donor eligibility determinations, including untimely infectious disease testing, inadequate screening for communicable diseases, and improper handling of HCT/Ps prior to complete eligibility. Additionally, donor eligibility records were found to be inaccurate, illegible, or incomplete.

Company: Chelsea Fertility NYC
Inspection Date: November 22, 2024
Product Type: Biologics
Office: New York District Office
Person: Irina Gaberman (Investigator)

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