Manhattan Fertility Services LLCNovember 5, 2024

FDA 483 - Manhattan Fertility Services LLC - November 05, 2024

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Record Details

Manhattan Fertility Services LLC in New York was cited for significant deficiencies related to donor screening, eligibility determination, and labeling of human cells, tissues, and cellular and tissue-based products (HCT/Ps). The inspection revealed inadequate procedures for donor screening, failure to determine donor eligibility based on complete screening and testing, and improper labeling of HCT/Ps from ineligible donors. Additionally, donor eligibility records were found to be inaccurate and incomplete.

Company: Manhattan Fertility Services LLC
Inspection Date: November 5, 2024
Product Type: Biologics
Office: New York District Office
Person: Irina Gaberman (Investigator)

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ID · 2afc305c-89b9-4d19-93e1-8dba4189735c