WASHINGTONKabco Pharmaceuticals, Inc., a contract manufacturer of vitamins and nutraceuticals, has been authorized by the FDA to resume operations 1 ½ years after a judge enjoined the company from manufacturing and distributing dietary supplements.
Effective Sept. 24, FDA formally authorized Kabco to resume its manufacturing operations, said Yousuf Rezaur, chief operating officer of the Amityville, New York-based company.
Kabco is in the process of hiring and training personnel, Rezaur said. He recently noted the company began receiving orders from customers and anticipates resuming operations soon.
Siobhan DeLancey, a spokesperson with FDA, confirmed the agency authorized Kabco to resume operations after FDA conducted two inspections and received additional information from the company that addressed its concerns.
“It is important to note that Kabco is still subject to the requirements of the Consent Decree," DeLancey said, “and that the FDA will continue to monitor the company’s compliance with the Consent Decree, the Federal Food, Drug, and Cosmetic Act, and the Act’s implementing regulations."
In April 2013, the U.S. Justice Department announced that a federal judge had entered a consent decree of permanent injunction against Kabco and its president, Abu Kabir, in the U.S. District Court for the Eastern District of New York.
The Justice Department previously alleged Kabco distributed supplements that failed to meet product specifications. According to a complaint, FDA investigators who inspected Kabco’s manufacturing facilities uncovered numerous violations of cGMPs (current Good Manufacturing Practices). The violations allegedly included failure to review and investigate product complaints, failure to hold supplements under conditions that prevent product mix-ups, and failure to label raw ingredients, including whey polio, an undeclared allergen.
Kabco’s entanglements with FDA date back at least four years when the agency warned the company in a letter that it was violating cGMPs.