FDA 483 - Huntington Reproductive Center Medical Group - March 28, 2023

An FDA inspection of Huntington Reproductive Center Medical Group in Newport Beach, CA, identified two significant issues regarding Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). The firm failed to maintain donor anonymity by including identifying personal information on records for 31 anonymous oocyte donors. Additionally, donor eligibility was determined prematurely, prior to the completion of required screening and testing procedures.