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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
Failure to document design inputs and outputs for its Lubricity dry mouth sprayer, as well as numerous other quality system lapses were uncovered during an inspection of YFS Pharma’s Buffalo, New York facility. Read More