FDA 483 - Loma Linda University Center for Fertility and IVF - July 19, 2024

The FDA conducted an inspection of Loma Linda University Center for Fertility and IVF from July 9-19, 2024, identifying significant deviations from regulatory requirements for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P). The inspection revealed six observations, with two being repeat findings.

Key issues included a failure to properly determine donor eligibility. Specifically, the firm did not ensure complete screening and testing for all oocyte donors, such as missing West Nile Virus tests for one donor and unresolved discrepancies in screening questionnaires for another. Furthermore, HCT/Ps from ineligible donors or those with incomplete eligibility assessments were not labeled with the required communicable disease risk warnings.

The facility also lacked established and maintained procedures for donor testing, screening, and eligibility determination, failing to include Hepatitis B Virus (HBV) Nucleic Acid Test (NAT) and corneal scarring screening. Crucially, donor eligibility procedures had not been reviewed and approved by a responsible person since June 2020, impacting the control of screening forms and documentation. The firm also failed to document the names and addresses of communicable disease testing laboratories and the establishment’s own address on donor eligibility records.

These observations indicate a need for comprehensive corrective actions to ensure compliance with FDA regulations governing HCT/P establishments, particularly concerning donor eligibility, labeling, and procedural controls.