FDA 483 - University of Alabama at Birmingham Gamete Biology Lab - March 23, 2022

An FDA inspection of the University of Alabama at Birmingham Gamete Biology Lab in Birmingham, AL, revealed several deficiencies related to human cells, tissues, and cellular and tissue-based products (HCT/Ps). Key issues included inadequate record-keeping for communicable disease testing, lack of proper review and approval for donor eligibility procedures, and failures in timely specimen collection and donor eligibility determinations. The findings indicate significant concerns with the firm's compliance with regulations governing donor screening and testing.