FDA 483 - Simpex Medical Inc - June 28, 2024

An FDA inspection of Simpex Medical Inc, a specification developer of K-wire and S-pin medical devices in Fort Mill, SC, revealed five significant quality system deficiencies, including two repeat observations. The firm lacked adequate procedures for design controls, process validation, sampling plans, device labeling, and equipment calibration, indicating a systemic failure to meet regulatory requirements for medical device manufacturing. These findings suggest a high level of non-compliance impacting device quality and safety.