FDAnews Device Daily Bulletin
Medical Devices / Inspections and Audits

China’s Copious International Cited for MDRs, Complaints

Nov. 20, 2018

China’s Copious International fell short on submitting medical device reports and tracking complaints, as well as validation procedures, a Feb. 5 to Feb. 8 inspection of the firm’s Guang Dong, China facility revealed.

The Chinese firm’s MDR procedures didn’t define time frames for submitting reports to the FDA, and it didn’t record complaints related to products on the U.S. market, according to the seven-item Form 483.

In addition, the firm’s CAPA procedures didn’t include adequate requirements for investigating the cause of nonconformities relating to products, processes or the quality system.

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