Archive for May 2020
TGA Fines Oxymed Australia for COVID-19 Advertising Claims
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 GMP Letter
Read More483 Roundup: Six Devicemakers Rapped for Quality Lapses
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
Read MoreFDA Loosens Regulations on Digital Pathology Devices During Outbreak
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
Read MoreFDA Warns Chinese Devicemaker for Quality Failures
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
Read MoreThai Condom Manufacturer Draws Warning for GMP Failures
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 GMP Letter
Read MoreHungarian Devicemaker Warned for Poor Design, Process Controls
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
Read MoreEuropean Commission Delays MDR for Another Year Due to COVID-19
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
Read MoreIMDRF Calls for Harmonized Approach for Adverse Event Reports, Cybersecurity
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
Read MoreFDA Eases Supply Chain Requirements During Pandemic
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 GMP Report
Read More483 Roundup: FDA Cites Eight Firms for Quality Issues
The FDA found a range of quality lapses during inspections at eight U.S.-based plants. Source: Drug GMP Report
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