FDA 483 - MFC Lab, Inc. - April 30, 2025

MFC Lab, Inc. in Greenbrae, CA, a reproductive tissue facility, was inspected by the FDA from 4/29/2025 to 4/30/2025. The inspection revealed two significant issues related to the determination of HCT/P donor eligibility and the lack of established procedures for screening directed semen donors. These observations indicate deficiencies in donor screening and documentation practices.