483
Center for Human ReproductionCenter for Human Reproduction – FDA 483, Jul 20, 2022
Record Details
Northwell Health Fertility in Manhasset, NY, was inspected regarding its reproductive human tissue operations. The inspection revealed significant deficiencies in the screening and eligibility determination processes for HCT/P oocyte donors, including inadequate Zika Virus screening and untimely medical record reviews. Furthermore, the firm lacked established procedures for determining donor eligibility.
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ID · 43086d89-7db0-4f14-88b8-9f13d10c6ef7
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