FDA 483 - Innovative Med Inc. - April 15, 2025

KMI IMI Group dba Innovative Med Inc. in Irvine, CA, was inspected from April 14-15, 2025. The inspection revealed a repeat observation regarding the firm's internal audit process, where individuals conducting quality audits had direct responsibility for the matters being audited. Specifically, a regulatory consultant audited CAPAs for which she was responsible, indicating a significant lapse in quality system independence.