On June 15, 2017, the U.S. Food and Drug Administration (FDA) announced that U.S. District Judge Kathleen M. Williams for the Southern District of Florida entered a consent decree of permanent injunction between the United States and Stratus Pharmaceuticals Inc., of Miami, Florida, and Sonar Products Inc., of Carlstadt, New Jersey, along with two of the companies’ officers. The consent decree alleges that the two companies routinely shipped unapproved, misbranded (improperly labeled), and substandard adulterated, or contaminated drugs, in interstate commerce.
The products that were not approved by the FDA were manufactured by Sonar Products and distributed by Stratus Pharmaceuticals, which is a violation of the Federal Food, Drug, and Cosmetic Act. The affected products included dermatological products including various washes, creams, and ointments, according to PharmaTech.com.
Previous Action Taken Against Sonar and Stratus
This was not the only time action was taken against the two companies. In April 2015, more than $16 million in unapproved drugs were seized by U.S. Marshalls from the two companies. The unapproved products included: a solution marketed to treat excessive sweating; an antibiotic cleanser marketed for treatment of 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 problems; and drops used to treat ear pain.
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Violations Found During Inspections
FDA inspectors in 2014, found violations of current good manufacturing practices that included failure to handle over 1,300 consumer complaints and use of improperly cleaned equipment, and used test methods that allegedly lacked a scientific basis. The FDA found multiple instances where test results from samples that did not meet quality standards were replaced by those that did. Failing results were unreported and were not investigated.
During an inspection at Sonar’s facility, it was found that nonsterile water was used to make approximately 15 batches of product, nearly all of which went to market. Sonar did not investigate or attempt to isolate the source of the breach, even though the contaminated water failed microbial tests multiple times. According to the complaint, 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, reports the Miami Herald.
“These companies have endangered the public by selling products that have not been proven to be safe or effective and are poorly made,” stated Janet Woodcock, M.D., 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.”
The FDA is requesting the company to hire a CGMP (Current Good Manufacturing Practice) consultant and correct its violations. Sonar is required according to the consent decree to halt operations until it receives written permission from FDA to resume operation. The FDA said in a statement, it shut down Sonar Products. Inc, in Carlstadt, due to the allegations that the company manufactured unapproved pharmaceutical skin products.
Stratus is prohibited from distributing unapproved drugs until FDA approval for the affected products is obtained. The complaint was filed by the U.S. Department of Justice (DOJ) on behalf of the FDA.
“The seizure of these products is consistent with the enforcement policy set forth in the FDA’s Marketed Unapproved Drugs Compliance Policy Guide, which, among its other provisions, provides notice that any product that is being marketed illegally and the persons responsible for causing the illegal marketing of the product are subject to FDA enforcement action at any time,” according to the FDA website.
“Companies that market unapproved drugs are placing consumers at risk because the products may not be safe, effective, or made using quality manufacturing practices,” said Cynthia Schnedar, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “The FDA is committed to protecting consumers and will continue to take actions against companies that do not meet these standards.”
Legal Information and Advice Concerning Stratus Pharmaceuticals Product Liability?
If you or someone you know has been negatively affected by an unapproved product or pharmaceutical, you may have valuable legal rights. Parker Waichman LLP offers free, no-obligation case evaluations. We urge you to contact our personal injury attorneys at 1-800-YOURLAWYER (1-800-968-7529).