Australia’s Therapeutic Goods Administration (TGA) fined Oxymed Australia A$63,000 ($40,000) for making false claims that its hyperbaric oxygen therapy chambers can treat a variety of conditions, including COVID-19. Source: The…
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. Source: The GMP Letter
To expand their availability during the pandemic, the FDA has temporarily relaxed its regulations on the use of certain digital pathology devices in laboratories. Source: The GMP Letter
Failure to control nonconforming products landed Dongguan Microview Medical a warning letter following an FDA inspection of its facility in Guangdong, China. Source: The GMP Letter
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. Source:…
The FDA issued a warning letter to a devicemaker in Pest, Hungary for serious quality system failures, including inadequate design and process controls. Source: The GMP Letter
The European Commission has adopted a proposal to delay implementation of the EU Medical Device Regulation (MDR) for a year due to the COVID-19 pandemic. Source: The GMP Letter
The International Medical Device Regulators Forum (IMDRF) released final guidance on harmonized regulations for adverse event reporting, cybersecurity, and personalized medical devices. Source: The GMP Letter
To keep prescription drugs moving smoothly through the supply chain during the pandemic, the FDA released emergency final guidance exempting certain COVID-19 products from tracing and identification requirements. Source: Drug…
The FDA found a range of quality lapses during inspections at eight U.S.-based plants. Source: Drug GMP Report