483
California Fertility Centers, A Medical CorporationCalifornia Fertility Centers, A Medical Corporation – FDA 483, Jan 24, 2020
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.
- Inspection date
- January 24, 2020
- Product type
- biologics
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ID · 4e53dc14-e3e1-440b-8644-b4bbe468dd83
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