Enforcement Experts: COVID-19 Backlog Could Last Years
The US Department of Justice faces significant challenges in investigating and punishing bad behavior during the COVID-19 pandemic, attorneys say.
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Expect Surge In Recalls, Enforcement Actions When FDA’s Soft Touch Ends, Inspections Resume, Experts Warn
Two industry experts say device makers that became complacent during the coronavirus public health emergency will be in for a rude awakening when the US FDA retightens its regulatory grip after the worst of the pandemic fades. Aside from a probable uptick in enforcement actions, there will likely be a wave of product recalls in part because the agency passed out emergency use authorizations like Tic Tacs and paused routine surveillance inspections in March.
US FDA investigators are chasing down scammers selling fraudulent COVID-19 treatments and tests. The agency said it is working with online retailers and domain name registrars to pull the products off websites, as well as trying to prevent them from entering the country.
Pentax Medical is paying $43m to resolve criminal charges around the misbranding of the company’s endoscopes.