June 16, 2017
By Alex Keown, BioSpace.com Breaking News Staff
MIAMI – A federal judge has ordered Florida-based Stratus Pharmaceuticals and New Jersey-based Sonar Products, a manufacturing company, to cease the manufacturing and distribution of drugs that are unapproved, mislabeled or contaminated.
U.S. District Judge Kathleen Williams issued a consent decree of permanent injunction following a complaint filed by the U.S. Food and Drug Administration. According to the FDA complaint, Stratus and Sonar routinely shipped the problematic drugs, which were primarily dermatological, across state lines. The FDA said in its complaint that the products had not received regulatory approval and were in violation of the Federal Food, Drug, and Cosmetic Act. The products the two companies were accused of distributing without regulatory approval include washes, creams and ointments. The FDA complaint singled out Stratus executives Alberto Hoyo and Juan Carlos Billoch, who also serve on the board of directors for Sonar.
Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said Sonar and Stratus endangered the public through the manufacture of the products that “have not been proven to be safe or effective and are poorly made.”
The FDA said it has been cataloguing problems with the two companies since 2014. The two companies have been in violation of current good manufacturing practice (CGMP) requirements. Among the violations was a mishandling of more than 1,300 consumer complaints by Stratus. Sonar, the FDA said, used components in its manufacturing that did not meet “established standards or specifications.” Additionally, the FDA said Sonar “failed to properly clean manufacturing equipment and used test methods that lacked a scientific basis.” Sonar’s violations included using non-sterile water to manufacture the dermatological products, improper cleaning and maintenance of manufacturing equipment and quality assurance failures that were never addressed, according to reports.
The problems for the two companies continued in 2015. That year, U.S. Marshalls unapproved prescription drug products valued at more than $16 million.
The ruling now handcuffs the two companies significantly. Sonar has been ordered to cease operations until it hires a CGMP expert, corrects the numerous violations the FDA found and receives authorization from the FDA to resume operations. Stratus is prohibited from distributing unapproved drugs until it obtains required FDA approvals for those products.
Olga Vieira, an attorney for Stratus, told the Miami Herald in an email, that the company’s agreement to the consent decree is an economic decision and not an admission of guilt to any of the charges levied by the FDA.
“Those allegations were based on inspections of Sonar Products Inc. that happened more than two years ago, with no subsequent negative observations of any kind against Stratus, and no recalls, afterward,” Vieira told the Herald.
Additionally, Vieira said Stratus is shutting down Sonar in order to assure full compliance with current good manufacturing practice requirements. All of Stratus’ products will now be manufactured in a “state-of-the-art facility in South Florida” to ensure quality control, Vieira said.
“The agency will continue to take aggressive enforcement action against those who repeatedly violate the law and put consumers at risk,” Woodcock said in a statement.
