A federal court has permanently enjoined an Arizona company from distributing adulterated supplements. The complaint, which was filed on October 12, 2022, enjoined Global Vitality, Inc., doing business as Enzyme Process International, from distributing these adulterated supplements, which were also misbranded.
The complaint was filed in the U.S. District Court of the District of Arizona. FDA alleges that inspectors visited the Global Vitality facility in Chandler, Arizona many times, in 2012, 2014, 2016, 2019, and in June and July 2021, and found violations of regulatory requirements meant to control the risk of hazards in dietary supplements. The government also alleges that the company failed to follow current good manufacturing practices for dietary supplements. In addition, a quality control failure at the facility allegedly led to a positive test for E. coli in one of the products.
The FDA’s Associate Commissioner for Regulatory Affairs Judith McMeekin, Pharm.D said in a statement, “Protecting the American public’s access to safe and quality-made products is a core function of the FDA’s public health work. To do so, the agency will continue to use all of the regulatory tools available and work with our federal law enforcement partners at the Department of Justice to ensure firms meet acceptable regulatory requirements for quality. Today, these standards were again upheld. Global Vitality Inc. (doing business as Enzyme Process International), along with company owner Steven D. Roderick and company corporate secretary Gorica Blagojevic, will be required to comply with federal law.”
The defendants agreed to settle the suit and be bound by a consent decree of permanent injunction. The defendants must come into compliance with the law and retain independent experts in labeling and current good manufacturing practices.
