FDA 483 - Pace Tech, Inc. - November 15, 2024

An FDA inspection of Pace Tech, Inc. in Clearwater, FL, a manufacturer of medical devices, revealed significant quality system deficiencies. The firm failed to properly label its VitalMax and MiniPack patient cardiac monitors with Unique Device Identifiers (UDI), did not document acceptance activities in the device history record, and lacked established procedures for corrective and preventive action. These observations indicate a need for comprehensive improvements in the firm's quality management system.