FDA 483 - M3 Global Enterprises LLC - February 16, 2023

M3 Global Enterprises LLC, a medical device manufacturer in Beavercreek, OH, was inspected by the FDA from February 13-16, 2023. The inspection revealed significant deficiencies in the firm's quality system, specifically regarding complaint handling and purchasing controls. The firm failed to adequately document and evaluate complaints and lacked established procedures and records for ensuring purchased products and services conform to specified requirements.