Nevada-Based Real Water agrees to stop production until they can comply with FDA regulations

The FDA announced that Real Water Inc., a Nevada-based bottled water manufacturer, agreed to cease operations until they comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other requirements listed in a consent decree. On June 1, U.S. District Judge Jennifer A. Dorsey entered a consent decree of permanent injunction between Real Water and its principles. The consent decree requires defendants to cease operations until they complete corrective actions.  “We are committed to preventing harmful products from entering the nation’s food supply, and we will take enforcement action when a company fails to follow the law,” said FDA Associate Commissioner for Regulatory Affairs Judy McMeekin, Pharm.D. “The FDA, together with our federal counterparts at the U.S. Department of Justice (DOJ), aggressively pursued this injunction, and we will continue to take swift action to protect consumers.”The complaint by DOJ accuses the company of failing to meet CGMP requirements and producing products under unsanitary conditions. The product caused 16 cases of acute non-viral hepatitis in adults, including one death of a woman with underlying medical conditions. Under the consent decree, defendants may not resume operations until they establish and implement procedures that are adequate to ensure continuing compliance with CGMP and preventive controls requirements and receive authorization from the FDA.  @ https://www.fda.gov/news-events/press-announcements/nevada-based-bottled-water-manufacturer-agrees-stop-production-failure-comply-manufacturing?utm_medium=email&utm_source=govdelivery