Three Manufacturers Fail to Meet GMP Standards; FDA Intervenes

July 14, 2009

FDA has requested a court order be issued on Quality Formulation Laboratories, American Sports Nutrition Inc., Sports Nutrition International LLC (Paterson, NJ), and Mohamed S. Desoky, the overseer of operations at all three companies.

FDA has requested a court order be issued on Quality Formulation Laboratories, American Sports Nutrition Inc., Sports Nutrition International LLC (Paterson, NJ), and Mohamed S. Desoky, the overseer of operations at all three companies.

The complaint, filed July 1 by the US Department of Justice (Washington, DC) on behalf of FDA, alleges that each of the companies failed to improve its "filthy" conditions of product manufacturing and storing after three investigations. FDA alleges that the companies did not meet GMP standards. Major food allergens in products were not labeled and evidence of live and dead rodents was found.

"This company has consistently failed to correct filthy conditions in their plants and to make sure that allergens are appropriately declared on the labels, despite frequent warnings to do so," said Michael Chappell, FDA's associate commissioner for regulatory affairs. "The FDA will not tolerate companies that fail to provide adequate safeguards."

-Robby Gardner

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