FDA 483 - Loma Linda University Center for Fertility and IVF - March 02, 2023

The FDA inspected Loma Linda University Center for Fertility and IVF from February 23 to March 2, 2023, issuing a Form FDA 483 that highlighted critical deficiencies in donor screening and record-keeping. The primary concern was the inadequate screening of oocyte and semen donors for communicable diseases such as West Nile Virus, syphilis, and Zika Virus, with these lapses noted since 2017. Despite these oversights, donors were deemed eligible, and their genetic material was subsequently used in fertility procedures for recipients.

Specifically, the firm failed to implement and maintain comprehensive procedures for testing and determining donor eligibility for human cells, tissues, and cellular and tissue-based products (HCT/Ps). This included insufficient screening for various viral agents and syphilis risk factors. The inspection also revealed instances where donors were declared eligible without complete required communicable disease agent screening records or physical assessments. Furthermore, the firm compromised donor anonymity by including personal identifying information, like names and dates of birth, on records for anonymous oocyte donors.

These observations underscore a failure to comply with federal regulations governing reproductive tissue banks, which are designed to ensure donor safety and prevent the transmission of communicable diseases through donated materials. Loma Linda University Center for Fertility and IVF is expected to implement prompt corrective actions to address these serious findings and achieve full regulatory compliance.