Manhattan Reproductive Medicine, PCFebruary 12, 2020

FDA 483 - Manhattan Reproductive Medicine, PC - February 12, 2020

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Record Details

Manhattan Reproductive Medicine,PC, a reproductive human tissue establishment in New York, NY, was cited for two observations during an FDA inspection. The firm failed to adequately screen oocyte donors for all relevant communicable disease risk factors, specifically concerning Zika virus (ZIKV) exposure. Additionally, the company lacked established and maintained procedures for screening and determining the eligibility of HCT/P donors.

Company: Manhattan Reproductive Medicine, PC
Inspection Date: February 12, 2020
Product Type: Biologics
Office: Division of Human and Animal Food Operations - East I
People: Monika Borkowska (investigator)
Irina Gaberman (Investigator)

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ID · 8d723eb2-e38b-4caf-bbc7-daa6b04ab3bf