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A consent decree of permanent injunction was entered between the United States and the two companies due to unapproved, mislabeled, and adulterated drugs.
FDA announced on June 15, 1017 that US 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 Inc. (Miami, FL), Sonar Products Inc. (Carlstadt, NJ) and two of the companies’ officers, Alberto Hoyo and Juan Carlos Billoch. The consent decree claims the two companies shipped unapproved, misbranded, and adulterated drugs.
According to FDA, products not approved by the agency were manufactured by Sonar Products and distributed by Stratus Pharmaceuticals, a violation of the Federal Food, Drug, and Cosmetic Act. The products included washes, creams, and ointments.
This is not the first time action was taken against the two companies. US Marshalls seized more than $16 million in unapproved drugs from the companies in April 2015. In 2014, FDA inspectors found violations of current good manufacturing practices (CGMPs) including failure to handle more than 1300 consumer complaints and use of improperly cleaned equipment.
“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, MD, director of the FDA’s Center for Drug Evaluation and Research in a statement. “The agency will continue to take aggressive enforcement action against those who repeatedly violate the law and put consumers at risk.”
FDA is asking the company to hire a CGMP consultant and correct its violations. Sonar is required by the consent decree to halt operations until it receives written permission from FDA to resume operation. Stratus is prohibited from distributing unapproved drugs until FDA approval for the products is obtained.