FDA 483 - C.A.R.E. Fertility - October 26, 2023

An FDA inspection of C.A.R.E. Fertility, a reproductive fertility center located in Glendale, CA, was conducted from October 24-26, 2023. The inspection identified six significant observations indicating non-compliance with regulations concerning human cell and tissue products. A primary concern was the inadequate screening of oocyte donors since April 2019 for communicable disease risks, including Creutzfeldt-Jakob Disease (CJD) and Zika virus. Specifically, donor medical history forms lacked critical questions regarding travel to specific regions (e.g., Turkey, UK) and complete transfusion history (e.g., France), and failed to use gender-neutral language for sexual contact. Correspondingly, the firm's donor eligibility determination procedures were found to be deficient, not adequately addressing risk factors for West Nile Virus, CJD, and Zika, with similar omissions in their protocols. Further violations included the failure to properly quarantine human cell and tissue products from inadequately screened donors. The facility also did not apply required warning labels to products from donors who had not met eligibility requirements, nor did they include a biohazard legend where appropriate. Additionally, donor anonymity was compromised, as accompanying records for anonymous oocyte donors contained identifying information such as names or dates of birth. Finally, critical donor eligibility records, including the Donor Eligibility Determination Form and Summary of Record for directed oocyte donors, were not retained for the mandated 10-year period. C.A.R.E. Fertility is expected to implement comprehensive corrective actions to address these observations and ensure adherence to federal standards for human tissue product handling and safety.