Failure to validate reprocessing instructions for its Class II reusable menstrual cups and a host of other quality issues landed Dot International a seven-item Form 483 following an FDA inspection…

Process control procedures were found to be lax during an FDA inspection of Hudson Scientific’s Hudson, Michigan facility. Source: The GMP Letter

Failure to submit medical device reports to the FDA within the prescribed timeframe and lax complaint handling landed duodenoscope maker Olympus a Form 483 following an FDA inspection of its…

The FDA has granted Abbott Laboratories an Emergency Use Authorization for its COVID-19 antigen test, a diagnostic that provides fast, readable results on a card similar to some pregnancy tests.…

Recalls in the medical device industry are a business activity — not just something that the regulatory and quality teams do. Source: The GMP Letter

The European Commission has established common specifications for reprocessing single-use devices under the EU Medical Device Regulation. Source: The GMP Letter