MIAMI (Legal Newsline) — The U.S. Department of Justice announced on June 15 that the U.S. District Court for the Southern District of Florida entered a consent decree of permanent injunction against Stratus Pharmaceuticals Inc. of Miami; Sonar Products Inc. of Carlstadt, N.J.; and individuals Alberto Hoyo and Juan Carlos Billoch.
The injunction bars the defendants from distributing unapproved, misbranded and adulterated drugs in violation of the Food, Drug and Cosmetic Act (FDCA).
According to the allegations, the defendants had shipped drugs that were not approved by the U.S. Food and Drug Administration (FDA). Additionally, they purportedly failed to follow federal rules relating to good manufacturing practices.
“Compliance with the Food, Drug,and Cosmetic Act is necessary to ensure the safety and effectiveness of the medicines we all use,” Chad A. Readler, acting assistant attorney general of the Justice Department’s Civil Division, said. “The department will continue to work closely with the FDA to protect the public from conduct like that alleged in the complaint, which poses a potential risk to consumers.”
Handling the case for the U.S. were trial attorneys Jacqueline Blaesi-Freed and Monica Groat of the Civil Division’s Consumer Protection Branch and assistant U.S. attorney James Weinkle of the U.S. Attorney’s Office for the Southern District of Florida. Joshua Davenport, associate chief counsel for enforcement of the FDA’s Office of General Counsel, Department of Health and Human Services, also assisted.