Editor's Note: A California District Court entered a consent decree of permanent injunction against GM Manufacturing Inc. (GMM) for failing to address alleged cGMP violations identified by FDA inspectors in 2012 and 2013. FDA inspections established that the defendants' dietary supplements were adulterated because they were allegedly prepared, packed and held under conditions that do not comply with cGMP for dietary supplements. As part of the permanent injunction, the defendants agreed to stop manufacturing, preparing and distributing dietary supplements and are required to recall all dietary supplements manufactured, prepared, processed, packed, labeled, held, and/or distributed at any time since Feb. 13, 2012. Defendants are then required to destroy all dietary supplements in their possession, custody and/or control.
Department of Justice
The Justice Department announced today that U.S. District Court Judge Otis D. Wright II of the Central District of California entered a consent decree of permanent injunction against GM Manufacturing Inc. (GMM) and Mao L. Yang, Mary Chen and David Yang on Friday, June 20, 2014, to prevent the distribution of adulterated dietary supplements.
"Adulterated dietary supplements may pose a significant risk to the public health," said Stuart F. Delery, Assistant Attorney General for the Department of Justice's Civil Division. "The Department of Justice is committed to protecting the public from dietary supplements that are not manufactured in conformity with current good manufacturing practices as required by law."
According to the complaint filed by the United States on June 2, 2014, GMM manufactured, labeled, prepared, packed, held and distributed dietary supplements from its facility in Gardena, California. As alleged in the complaint, inspections by the Food and Drug Administration (FDA) established that the dietary supplements manufactured and distributed by the defendants were adulterated, in that they were prepared, packed and held under conditions that do not comply with the current good manufacturing practice regulations for dietary supplements. For example, during an inspection in 2013, FDA observed that defendants failed to maintain, clean and sanitize, as necessary, equipment, utensils and other contact surfaces used to manufacture, package, label or hold components or dietary supplements.
As part of the permanent injunction, the defendants agreed to stop manufacturing, preparing and distributing dietary supplements. The defendants agreed to provide 90 days' notice to FDA before seeking to resume operations. If the defendants seek to resume dietary supplement operations, they are required to comply with a series of remedial measures, including retaining an expert to inspect the company's facility and provide a certification that all manufacturing deficiencies have been corrected. Also, the defendants must report to FDA all actions they have taken to correct the deviations. The defendants are not allowed to resume operations until FDA has re-inspected their facility and operations, and provided written notice to them.
According to the complaint, the defendants' facility was inspected by FDA in 2012 and 2013. During the 2013 inspection, the FDA observed significant violations of the Federal Food, Drug, and Cosmetics Act and implementing regulations, including violations that were the same or similar to those observed during the 2012 inspection. Following the 2012 inspection, FDA issued a warning letter to Mao Yang informing him that the significant deviations documented by FDA during the 2012 inspection rendered defendants' dietary supplements adulterated under the law. The warning letter from FDA cautioned that failure to promptly correct the deviations, and prevent future ones, could lead to additional regulatory action, including an injunction.
Despite the inspections and warning letter from FDA, the defendants continued to manufacture and distribute adulterated dietary supplements in violation of the law.
The permanent injunction entered by the district court requires the defendants to recall all dietary supplements that the defendants manufactured, prepared, processed, packed, labeled, held, and/or distributed at any time since Feb. 13, 2012. Defendants are then required to destroy all dietary supplements in their possession, custody and/or control.
Assistant Attorney General Delery thanked the FDA for referring this matter to the Department of Justice. Trial Attorney Lauren Fascett of the Civil Division's Consumer Protection Branch, in conjunction with Assistant U.S. Attorney Brian Villarreal in the Central District of California and Associate Chief Counsel Leslie Cohen of the Office of General Counsel, Enforcement of the Food and Drug Division, Department of Health and Human Services, brought this case on behalf of the United States.
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