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SILVER SPRING, Md. — A permanent injunction was granted to the federal government Tuesday against a contract manufacturer and distributor of prescription and over-the-counter products, as well as two of its executives.
In a complaint filed by the Department of Justice in the U.S. District Court for the Southern District of Texas, officials said that Deltex Pharmaceuticals and its president and VP, Kabir Ahmed and Mohidur Khan, violated the Federal Food, Drug, and Cosmetic Act by failing to obtain required approval from the Food and Drug Administration for its prescription drugs, as well as failing to comply with FDA regulations governing OTC drug products and current good manufacturing practice requirements.
In 2008, the FDA said it issued a warning letter to the company over its manufacturing of unapproved drugs and for deviations from cGMP requirements. Under the injunction, Deltex must comply with all federal requirements before continuing the manufacturing and distributing of its prescription and OTC products.
"This injunction shows that the FDA will seek enforcement action against companies that are identified as being in violation of our manufacturing and drug approval requirements," said Dara Corrigan, FDA's associate commissioner for regulatory affairs.