FDA 483 - Texas Tech University Health Sciences Center Center for Fertility and Reproductive Surgery - July 26, 2023

An FDA inspection of Texas Tech University Health Sciences Center, Center for Fertility and Reproductive Surgery, identified four significant issues. The firm failed to use FDA-licensed tests for communicable disease screening, did not quarantine HCT/Ps until donor eligibility was determined, and omitted required record summaries for shipped reproductive tissue. Additionally, the facility lacked adequate procedures for screening HCT/P donors, including for Zika Virus risk factors.