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The FDA cited six U.S. devicemakers for a variety to quality failures including failing to submit medical device reports or to maintain a device master record. Read More
Failure to control nonconforming products landed Dongguan Microview Medical a warning letter following an FDA inspection of its facility in Guangdong, China. Read More
The FDA slapped Thai condom manufacturer Okamoto Rubber Products with a warning letter after receiving an inadequate response to a 483 following an inspection of the firm’s Pathumthani site. Read More
The FDA issued a warning letter to a devicemaker in Pest, Hungary for serious quality system failures, including inadequate design and process controls. Read More
The move is expected to minimize disruptions by reducing the need for on-site inspections where social distancing might be difficult to achieve, the agency said. Read More
Australia’s Therapeutic Goods Administration is conducting domestic good manufacturing inspections remotely in place of on-site inspections during the COVID-19 pandemic. Read More