California IVF Fertility Center – FDA 483, Oct 7, 2020
An FDA inspection of California IVF Fertility Center, a human tissue establishment in Sacramento, revealed a significant issue regarding the labeling of human cells, tissues, and cellular and tissue-based products (HCT/Ps). The firm failed to prominently label HCT/Ps from donors who were not adequately screened for communicable disease risks, including West Nile Virus, Zika Virus, and Creutzfeldt Jakob Disease, with the required warning statements. This indicates a failure to ensure the safety and proper identification of reproductive tissues.
ID · 1815bd14-eed0-4134-a22e-8b84f924c828
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