Pharmaceutical Company to Cease Operations Over Unapproved Drug Distribution

US District Judge Kathleen M. Williams of the Southern District of Florida recently entered a consent degree of permanent injunction for Stratus Pharmaceuticals Inc and Sonar Products Inc. The injunction also includes Alberto Hoyo and Juan Carlos Billoch, who were officers at the companies, according to a press release.

According to the complaint, both companies were involved with shipping unapproved drugs, as well as pharmaceuticals that were misbranded, substandard, or adulterated, the FDA reported.

Specifically, Stratus and Sonar distributed dermatological products that were not approved by the FDA. The distribution of the facial washes, creams, and ointments was in direct 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, 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 2015, US Marshalls seized unapproved prescription products that were manufactured by Sonar and distributed by Stratus, according to the release. In total, the products were valued at more than $16 million, and included:

• a solution to treat excessive sweating
• an antibiotic cleanser to treat skin conditions, including acne, rosacea, and seborrhea
• a topical ointment to treat wounds
• a topical cream and gel to treat psoriasis, eczema, and other skin conditions
• drops to treat ear pain

Further inspections by the FDA revealed that the companies also violated current good manufacturing practice requirements. The inspections revealed that Stratus failed to handle more than 1300 complaints from customers, according to the release.

It was also found that Sonar manufactured and sold adulterated drugs, did not properly clean equipment, and did not base testing methods on scientific practice. The FDA also discovered that Sonar used components in the products that did not meet specific standards, according to the release.

The consent decree requires that Sonar cease all operations until they hire a CGMP expert and correct violations, according to the release. To resume operations, Sonar requires written permission from the FDA. Additionally, Status is barred from distributing unapproved drugs.

The original complaint against Sonar and Stratus was filed by the US Department of Health and Human Services on behalf of the FDA, the press release concluded.