Center for Human ReproductionMarch 12, 2020

FDA 483 - Center for Human Reproduction - March 12, 2020

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Record Details

Northwell Health Fertility in Manhasset, NY, was inspected regarding its reproductive human tissue operations. The inspection revealed a significant issue with donor screening, specifically the failure to adequately screen oocyte donors for Zika Virus risk factors. This indicates a potential risk of transmitting communicable diseases through donated tissues.

Company: Center for Human Reproduction
Inspection Date: March 12, 2020
Product Type: Other
Office: Division of Human and Animal Food Operations - East I
Person: Irina Gaberman (Investigator)

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ID · e07b5631-22d4-4a1c-875c-c63b1e2e0a64