FDA 483 - Huntington Reproductive Center Medical Group - November 06, 2023

An FDA inspection of Huntington Reproductive Center Medical Group in Pasadena, CA, a reproductive fertility center, revealed significant deficiencies in their handling of HCT/Ps. The firm failed to properly determine donor eligibility, quarantine HCT/Ps, and apply appropriate warning labels for products from donors who were not adequately screened or had reactive test results for infectious substances. These issues indicate a failure to ensure the safety and proper processing of human cells and tissues.