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Medical Devices / Inspections and Audits

FDA Hits South Korean Firm for Quality Failures

Sept. 24, 2018
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FDA inspectors found numerous quality system failures at the Mi Gwang Contact Lens Company in South Korea during a March inspection.

The firm’s facility 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 agency’s Form 483.

Manufacturing processes were not developed to ensure that the devices met specifications, and device history records were incomplete and lacked vital data, the agency said.

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