California Fertility Centers, A Medical CorporationJanuary 24, 2020

FDA 483 - California Fertility Centers, A Medical Corporation - January 24, 2020

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Record Details

An FDA inspection of California Fertility Centers, A Medical Corporation in Pasadena, CA, revealed significant deficiencies in their donor screening process. The firm failed to adequately screen gamete and oocyte donors for communicable disease agents, including Zika virus, and other critical risk factors. This was due to an incomplete "Gamete Donor Screening Questionnaire" that omitted essential questions for assessing donor eligibility.

Company: California Fertility Centers, A Medical Corporation
Inspection Date: January 24, 2020
Product Type: Biologics
Office: Division of Pharmaceutical Quality Operations IV
Person: Yvonne C. Wilkes (investigator)

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ID · 4e53dc14-e3e1-440b-8644-b4bbe468dd83