FDA 483 - Charity Helpers Foundation - March 01, 2024

An FDA inspection of Charity Helpers Foundation in Salt Flat, TX, a reproductive HCT/P establishment, revealed critical failures in donor screening, testing, and eligibility determination for semen donations. The firm did not test donors for communicable diseases, review medical records, or establish proper procedures for donor eligibility. Additionally, essential records were not retained, and HCT/Ps were shipped without quarantine prior to eligibility determination, posing significant health risks.