UPDATE: On April 4, 2013, in the Eastern District of New York, Judge Joseph F. Bianco entered a consent decree of permanent injunction in this case. Kabco Pharmaceuticals, Inc. and Abu M. Kabir are now prohibited from manufacturing, preparing, processing, packaging, packing, labeling, holding, and/or distributing any dietary supplements unless and until, among other things, their operations comply with the Federal Food, Drug and Cosmetic Act and current good manufacturing practice requirements for dietary supplements. Kabco and Mr. Kabir may not resume operations until they receive permission from the FDA.
FDA NEWS RELEASE
Consumer Inquiries: 888-INFO-FDA
FDA seeks to halt production, distribution of dietary supplements at NY company
Action follows repeated violations of current good manufacturing practice requirements at Kabco Pharmaceuticals, Inc.
The U.S. Food and Drug Administration is seeking an injunction requiring Kabco Pharmaceuticals Inc., and owner Abu Kabir, of Amityville, N.Y., to stop producing and distributing dietary supplements until they comply with the Federal Food, Drug and Cosmetic Act and current good manufacturing practice (cGMP) requirements for dietary supplements.
The government’s complaint, filed today by the U.S. Department of Justice, alleges that Kabco Pharmaceuticals, Inc. and Mr. Kabir have violated the Act by manufacturing dietary supplements under conditions that do not meet the cGMP requirements.
FDA inspections found that Kabco distributed dietary supplements that did not meet product specifications. The company did not review and investigate product complaints, and Kabco also failed to hold dietary supplements under conditions designed to prevent product mix-ups.
The dietary supplements produced by Kabco Pharmaceuticals include Brewers Yeast Tablets, Dandelion Root Capsules, Night-Time Herb Capsules, Inositol Calcium & Magnesium Capsules, Vitamin C-500 with Rose Hips Time Released Tablets, and Joint All Capsules.
“FDA works with firms to ensure that their processes comply with the public health requirements in our laws and regulations,” said Dara A. Corrigan, associate commissioner for regulatory affairs. “But when a firm refuses to comply, we will take aggressive enforcement action.”
The complaint was filed in the U.S. District Court for the Eastern District of New York. If entered, the injunction would require Kabco to stop manufacturing and distributing dietary supplements until, among other corrective actions, the company demonstrates to the FDA that it is meeting the quality, safety, and labeling standards required by law.
Any illnesses or adverse events related to the use of Kabco Pharmaceuticals’ products should be reported to the FDA at email@example.com
or by calling 240-402-2405.
For more information:
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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