U.S. District Judge Kathleen M. Williams for the Southern District of Florida entered a consent decree of permanent injunction between the United States and Stratus Pharmaceuticals of Miami, Florida; Sonar Products of Carlstadt, New Jersey; and two of the companies’ officers, Alberto Hoyo and Juan Carlos Billoch.
According to the complaint filed with the consent decree, Stratus and Sonar routinely shipped unapproved, improperly labeled (misbranded), and substandard or contaminated (adulterated) drugs in interstate commerce. Specifically, Sonar manufactured and Stratus distributed a number of dermatological products, including various washes, creams and ointments that were not approved by the U.S. Food and Drug Administration, in violation of the Federal Food, Drug, and Cosmetic Act.
“These companies have endangered the public by selling products that have not been proven to be safe or effective and are poorly made,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.
In April 2015, U.S. Marshalls seized unapproved prescription drug products manufactured by Sonar and marketed and distributed by Stratus valued at more than $16 million. Additionally, FDA inspections since 2014 found that Stratus and Sonar violated current good manufacturing practice (CGMP) requirements.
The consent decree requires Sonar to cease operations until, among other things, it hires a CGMP expert, corrects its violations and receives written permission from the FDA to resume operations. Stratus is further prohibited from distributing unapproved drugs until it obtains required FDA approvals for those products.
The complaint was filed by the U.S. Department of Justice on behalf of the FDA.