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California Firm, Execs in Dietary Supplement Scam
A California-based firm and its executives have been hit with a permanent injunction after allegedly selling adulterated dietary supplements, posing a significant risk to public health.
U.S. District Court Judge Otis D. Wright II of the Central District of California entered the 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 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. The FDA inspections 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.
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.
The permanent injunction 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 government. 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 the case.
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Key Facts
- State: California
- Category: Drug Trafficking|Fraud & Financial Crimes|White Collar Crime
- Source: DOJ Press Release ↗
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