483
Aligneage Fertility Laboratory, LLCFDA 483 - Aligneage Fertility Laboratory, LLC - October 21, 2025
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Record Details
Aligneage Fertility Laboratory, LLC in New York, NY, was inspected regarding its reproductive human tissue operations. The inspection revealed significant deficiencies in establishing and maintaining procedures for screening HCT/P donors, particularly directed semen donors. Issues included inadequate screening for communicable disease risk factors and inaccurate donor eligibility records.
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ID · d52d1926-b569-4aa3-8fe8-030b17dfc054