483
Rockefeller Fertility CenterRockefeller Fertility Center – FDA 483, Nov 5, 2021
Record Details
Rockefeller Fertility Center in New York, NY, was inspected regarding its human reproductive tissue operations, specifically oocyte donors. The inspection revealed significant deficiencies in screening donors for communicable disease risks, particularly Zika Virus, and a failure to establish and maintain adequate donor eligibility procedures. These issues indicate a lack of proper controls for ensuring donor safety and product quality.
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ID · 19530967-a004-456f-8f19-ce5f5bd91f0d
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