FDA 483 - Texas Tech University Health Sciences Center Center for Fertility and Reproductive Surgery - September 21, 2022

An FDA inspection of Texas Tech University Health Sciences Center in Lubbock, TX, identified significant violations related to donor screening and testing for communicable disease agents. The firm failed to collect donor specimens at appropriate times, did not test for all relevant communicable diseases, and neglected to properly screen donors through medical record reviews. Additionally, the facility used non-FDA-licensed tests for critical communicable disease agent screening, indicating serious deficiencies in their reproductive services.