483
Fertility Care of Orange County, A Medical CorporationFertility Care of Orange County, A Medical Corporation – FDA 483, Oct 7, 2024
Record Details
An FDA inspection of Fertility Care of Orange County, A Medical Corporation in Brea, CA, identified a critical deficiency in donor screening practices. The firm failed to adequately screen donors for communicable disease agents and diseases, including West Nile Virus, Creutzfeldt-Jacob Disease, and xenotransplantation risks. This was due to an incomplete medical and social screening questionnaire, indicating a significant compliance issue.
- Inspection date
- October 7, 2024
- Product type
- biologics
- Person
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ID · 5f2ac8ec-28d7-491e-8d10-432f15104984
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