USA – FDA issues warning for unauthorized COVID-19 tests

The FDA has sent out five new warning letters this month regarding misbranded and adulterated COVID-19 tests, as the agency continues to urgently target manufacturers and suppliers of unapproved COVID-19 products through its Operation Quack Hack.

The FDA launched the initiative in March 2020 to identify fraudulent FDA-regulated products during the pandemic. As of March 25 this year, it has identified more than 1,354 reports of fraudulent products related to COVID-19, including many devices.

Operation Quack Hack builds on the agency’s previous experience with illegal online pharmacies and includes a team of consumer safety officers, special agents and intelligence analysts who triage incoming complaints about fraudulent and unproven medical products…