FDA 483 - MIE America, Inc. - September 14, 2023

MIE America, Inc., an initial importer and servicer of nuclear medicine imaging machines in Elk Grove Village, IL, received a Form FDA 483 with three observations. The inspection revealed significant deficiencies in the firm's quality system, including inadequate corrective and preventive action procedures, a lack of established quality audit procedures, and management's failure to ensure the quality policy is understood and implemented throughout the organization. These issues indicate a systemic breakdown in maintaining a compliant quality system.