FDA 483 - California IVF Fertility Center - October 07, 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.