483
Fertility Care of Orange County, A Medical CorporationFDA 483 - Fertility Care of Orange County, A Medical Corporation - October 07, 2024
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Record Details
An FDA inspection of Fertility Care of Orange County, A Medical Corporation, an HCT/P reproductive establishment in Brea, CA, revealed a significant deficiency in donor screening. The firm failed to adequately screen donors for communicable disease agents such as West Nile Virus, Creutzfeldt-Jacob Disease, and xenotransplantation risks. This lapse in screening could compromise the safety of human cells, tissues, and cellular and tissue-based products.
- Inspection Date
- October 7, 2024
- Product Type
- Biologics
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ID · 3356a3d8-39df-4a65-922b-30f9750b9acb