Greenwich Fertility & Ivf Center, P.c.March 11, 2022

FDA 483 - Greenwich Fertility & Ivf Center, P.c. - March 11, 2022

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Record Details

An FDA inspection of Greenwich Fertility & Ivf Center, P.c. identified significant issues related to human reproductive tissue processing. Observations included inadequate screening of egg donors for communicable diseases, specifically Zika Virus, and failures in maintaining donor anonymity. Additionally, the facility's records for HCT/Ps did not properly document donor-eligibility determinations.

Company: Greenwich Fertility & Ivf Center, P.c.
Inspection Date: March 11, 2022
Product Type: Biologics
Office: Division of Northeast Imports
Person: Anthony N. Onianwa (Investigator)

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ID · ccb2c203-5fa4-4c31-bf86-9fa7813bb1da