FDA 483 - Schmidt, Richard Joseph MD Inc - March 05, 2025

Richard Joseph Schmidt, MD, Inc. in Mountain View, CA, a reproductive firm, was cited for significant deficiencies in its donor screening and HCT/P handling processes. The inspection revealed failures in screening donors for communicable diseases, inadequate labeling of HCT/Ps from ineligible donors, and insufficient documentation of screening results. Additionally, the firm lacked established procedures for determining donor eligibility and deferral.