FDA 483 - Monitor Instruments, Inc. - October 10, 2019

An FDA inspection of Monitor Instruments, Inc. in Hillsborough, NC, conducted on October 9-10, 2019, revealed a significant issue with equipment calibration. The firm failed to adequately establish procedures for routine calibration, inspection, checking, and maintenance of equipment. Specifically, several electronic test instruments were found to have exceeded their assigned 2-year calibration due dates.