FDA 483 - California IVF Fertility Center - October 11, 2019

An FDA inspection of California IVF Fertility Center in Sacramento revealed significant deficiencies in donor testing and screening for communicable diseases. The firm failed to test oocyte and semen donors for West Nile Virus using an FDA-licensed NAT test and did not adequately screen donors for Zika Virus, West Nile Virus, TSEs (including CJD), and HIV. Additionally, the facility lacked established and maintained procedures for determining HCT/P donor eligibility, including specific procedures for testing and screening for various infectious agents.