M3 Global Enterprises LLCFebruary 16, 2023

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

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Record Details

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.

Company: M3 Global Enterprises LLC
Inspection Date: February 16, 2023
Product Type: Device
Office: Cincinnati District Office
Person: Teresa Kastner (Consumer Safety Officer, Medical Device Specialist)

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ID · 20c58567-e718-47a1-9236-fa76905f0c90