Numerous quality system failures were uncovered at South Korea’s Mi Gwang Contact Lens Company during a March 2018 FDA inspection.
The firm’s plant in Gyeongsan-si had not identified quality data sources to be analyzed to minimize the impact of internal and external failures when it came to taking corrective and preventive action, according to the eight-item Form 483.
Manufacturing processes were not developed to ensure that devices conformed to specifications, and device history records were incomplete and lacked vital data.
Inspectors found that procedures for receiving, reviewing and evaluating complaints by a formally designated unit were not established. A number of complaints lacked product evaluations and inspection results, and document control procedures were not established.
Medical device reporting procedures didn’t include internal systems to determine when an event meets MDR reporting criteria.
In addition, procedures for management reviews were not established, and senior management didn’t participate in management review meetings.
Read the Mi Gwang Contact Lens Form 483 here: www.fdanews.com/09-20-18-migwangcontactlenscoltd483.pdf.