FDA inspections end in order to cease operations
Following years of FDA inspections, the US authority has ordered one pharma manufacturer to halt operations and a distributor to cease distributing unapproved drugs.
Last week, a consent decree of permanent injunction was reached between the US, Stratus Pharmaceuticals of Miami, Florida and Sonar Products of Carlstadt, New Jersey.
Stratus and Sonar shipped unapproved, misbranded and substandard drugs that were not US FDA approved, according to the complaint associated with the decree.
FDA inspections dating back to 2014 revealed that Stratus and Sonar had flouted good manufacturing practice requirements (GMPs).
Sonar manufactured and Stratus distributed the products in question, which included the likes of an antibiotic cleanser to treat skin conditions such as acne, drops to treat ear pain and an ointment to treat wounds.
“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, 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.”
Sonar produced and released contaminated drugs, failed to use fully sanitized manufacturing equipment and deployed test methods that lacked scientific basis.
Also, 1,300 customer complaints were not properly handled by Stratus, which marketted and distributed the drugs. In 2015, over $16 million of unapproved prescription drug products were seized from Stratus.
The decree depicts that Sonar halts operations until a CGMP expert is hired and violations are corrected. It can return to the market once it receives permission from the FDA. Stratus cannot distribute unapproved drugs until FDA approval is granted for those products.