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FDA orders dermatological drug manufacturer and distributor to cease operations
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United States District Judge Kathleen M. Williams for the Southern District of Florida issued a consent decree of permanent injunction against Stratus Pharmaceuticals and Sonar Products, as well as the companies’ officers, Alberto Hoyo and Juan Carlos Billoch, for routinely shipping unapproved, misbranded and substandard or adulterated drugs in interstate commerce, according to a press release issued by the FDA.
The release stated that Sonar manufactured and Stratus distributed numerous dermatological products, including several washes, creams and ointments that had not been approved by the FDA, violating 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,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in the release. “The agency will continue to take aggressive enforcement action against those who repeatedly violate the law and put consumers at risk.”
More than $16 million worth of unapproved drugs manufactured by Sonar and marketed and distributed by Stratus were seized by U.S. Marshalls in April 2015, according to the release. A solution for excessive sweating; an antibiotic cleanser for skin conditions, including acne, rosacea and seborrhea; a topical ointment for wounds; a topical cream and gel for psoriasis, eczema and other skin conditions; and drops for ear pain were among the unapproved products.
Since 2014, the FDA inspected Stratus and Sonar and found that they violated current good manufacturing practice (CGMP) requirements, according to the release. In addition, FDA inspectors found that Status did not properly handle more than 1,300 consumer complaints and Sonar manufactured and released contaminated drugs, used substandard components, neglected to appropriately clean manufacturing equipment and used unscientific test methods, according to the release.
Sonar is required to halt operations until it amends its violations, hires a CGMP expert and obtains written FDA permission before it can resume operations, while Stratus is prohibited from distributing products until it receives FDA approval, according to the FDA.
Disclosure: Healio Internal Medicine was unable to confirm relevant financial disclosures at the time of publication.