FDA 483 - Huntington Reproductive Center Medical Group - October 29, 2024

An FDA inspection of Huntington Reproductive Center Medical Group in Newport Beach, CA, identified two significant observations concerning their HCT/P operations. The firm failed to properly determine donor eligibility based on screening questionnaires, specifically regarding a donor's travel history. Additionally, personal identifying information, such as dates of birth, was found on accompanying records for anonymous oocyte donors.