A South Florida judge Thursday ordered a Florida-based pharmaceutical company and the New Jersey-based company that manufacturers its drugs to cease production of drugs that are unapproved, mislabeled or contaminated.
The permanent injunction follows a complaint filed last month by the Food and Drug Administration against Stratus Pharmaceuticals Inc. in Miami and Sonar Products Inc. in Carlstadt, New Jersey.
Sonar manufactures prescription drugs including topical creams and ointments, antibiotic face wash for acne and sweat-reducing products for Stratus. Defendants Alberto Hoyo, president of Stratus and Juan Carlos Billoch, vice president of Stratus,consented to the order. According to the complaint, Hoyo previously served as president and CEO of Sonar when the FDA warned Sonar about its practices; both he and Billoch are current Sonar board members, according to court documents.
According to the complaint, a former unnamed Sonar president acknowledged to the FDA in March 2014 that the firm was manufacturing unapproved drug products. Hoyo and Billoch were warned during a December 2015 inspection that they would face enforcement action if they continued to manufacture unapproved drugs.
On April 13, 2015, U.S. marshals seized unapproved and misbranded prescription drugs valued at more than $16 million from a Stratus facility.
“These products have not been proven safe and effective for their intended uses,” according to a FDA press release from April 16, 2015. It recommended that people who used Stratus Pharmaceuticals products consult a healthcare professional about alternative treatment options.
Stratus Pharmaceuticals and Sonar Products also have a history of violating current good manufacturing practices, as noted in four FDA facility inspections between March 2014 and April 2015, according to the complaint.
Sonar lacked protocols for equipment cleaning and maintenance, as well as for quality assurance checks on the raw materials and finished products. The FDA found multiple instances where test results from samples that didn’t meet quality standards were replaced by those that did. Failing results went unreported and were not investigated.
An inspection at Sonar’s facility also found that nonsterile water was used to make approximately 15 batches of product, nearly all of which went to market. Although the contaminated water failed microbial tests multiple times, Sonar did not investigate or try to isolate the source of the breach.
When samples were tested to evaluate the effectiveness of Sonar’s manufacturing sanitation procedures, the microbial levels came back “Too Numerous to Count (TNTC)” even after equipment was recleaned and sanitized, according to the complaint.
According to the injunction, Sonar is prohibited from drug production until appropriate manufacture practices are put in place, documented, inspected by an independent auditor hired by Stratus and Sonar and approved by the FDA. Stratus is prohibited from selling unapproved drugs until it receives FDA approval.
In an email to the Miami Herald, Olga Vieira, attorney for Stratus, said via an email to the Miami Herald, “Stratus Pharmaceuticals’ agreement to the Consent Decree entered by the Southern District of Florida is strictly an economic decision – and is in no way an admission of the specific allegations in the FDA’s Complaint. 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. At the same time, in order to assure full compliance with current good manufacturing practice (CGMP) requirements, Stratus has decided to shut down Sonar. All products sold by Stratus will now be made in a state-of-the-art facility in South Florida, which further guarantees the highest quality of products for their longstanding clients.”
Hoyo and Billoch are also registered officers for several corporations registered in Florida, according to the Florida Division of Corporations website. Those include Apiod Worldwide Inc., JCA Development of Miami Inc., Specialty Distributors Inc, HB Management Corp. and 142 Realty LLC. None of those companies was involved in this matter.