FDA 483 - iMed Technology, Inc - October 18, 2022

iMed Technology, Inc. in Carrollton, TX, was inspected by the FDA from October 17-18, 2022. The inspection identified a significant quality system deficiency related to internal audits. Specifically, individuals conducting quality audits had direct responsibility for the matters being audited, which violates the firm's own standard operating procedures for auditor independence.