After repeated infractions, a company is forced to shutter its doors.
The U.S. Justice Department, on behalf of the FDA, ordered a pharmaceutical manufacturer and distributor to cease operations until they correct violations and obtain FDA approvals for the products they are marketing.
The distributor Stratus Pharmaceuticals Inc. of Miami; and the manufacturer, Sonar Products Inc. of Carlstadt, NJ, along with two of the companies’ officers, Alberto Hoyo and Juan Carlos Billoch, must stop distributing prescription dermatological products, including ointments to treat eczema and psoriasis.
According to the complaint filed with the consent decree, Stratus and Sonar routinely shipped unapproved, misbranded, and substandard or contaminated (adulterated)drugs.
“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. “The agency will continue to take aggressive enforcement action against those who repeatedly violate the law and put consumers at risk.”
In April 2015, U.S. marshals seized more than $16 million worth of unapproved prescription drug products manufactured by Sonar and marketed and distributed by Stratus.
The unapproved drugs included: a solution marketed for excessive sweating; an antibiotic cleanser for skin conditions such as acne, rosacea, and seborrhea; a topical ointment marketed to treat wounds; a topical cream and gel marketed to treat psoriasis, eczema, and other skin conditions; and drops used to treat ear pain.
In addition, the FDA’s inspections since 2014 found that Stratus and Sonar violated Current Good Manufacturing Practice (CGMP) requirements and failed to properly handle more than 1,300 consumer complaints.
“Among other significant CGMP violations, Sonar manufactured and released adulterated drugs, used components that did not meet established standards or specifications, failed to properly clean manufacturing equipment, and used test methods that lacked a scientific basis,” FDA said in a statement.
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. In addition, Stratus cannot distribute unapproved drugs until it obtains required FDA approvals for those products.