the staff of the Ridgewood blog
Montvale NJ, Pentax Medical Company will pay $43 million to resolve criminal charges based on the company’s shipment of four types of endoscopes for 18 months without FDA-cleared instructions for use and the company’s failure to file timely reports of two infections associated with its endoscopes, the Department of Justice announced today.
Pentax was charged in a criminal complaint filed today in Newark federal court with distributing misbranded medical devices in interstate commerce in violation of the Federal Food, Drug, and Cosmetic Act (FDCA). Pentax has entered into a three-year deferred prosecution agreement (DPA) that will allow it to avoid conviction if it complies with the reform and enhanced compliance requirements outlined in the agreement. As a result of the conduct outlined in the criminal complaint, Pentax has agreed to pay a $40 million criminal fine and to forfeit $3 million.
