Federal Court Enters into Consent Decree with Tennessee Distributors

FDA announced on Sept. 3, 2019 that a US District Court Judge in Tennessee entered into a consent decree of permanent injunction against Basic Reset and Biogenyx, sole proprietorships, Fred R. Kaufman III, owner, and Kimberly Kaufman, after multiple FDA inspections of the companies’ facility found violations of the Federal Food, Drug, and Cosmetic Act. The company is accused of having unlawfully distributed unapproved new drugs, adulterated and misbranded dietary supplements, and an adulterated and misbranded device.

According to FDA, the agency has not approved the companies’ drugs or devices for uses claimed by the companies. During a facility inspection, FDA found violations of current good manufacturing practices (CGMPs) that included a failure to establish specifications for ensuring the identification of products received for labeling and a failure to investigate product complaints. FDA previously issued a warning letter for similar violations.

“Despite previous warnings, Basic Reset and Biogenyx placed consumers at risk by distributing certain products in violation of current good manufacturing practice (CGMP) requirements and products which failed to adequately meet labeling standards. The U.S. Food and Drug Administration remains fully committed to taking enforcement action against companies and owners who place unsuspecting American consumers at risk,” FDA Commissioner Ned Sharpless, MD, said in a statement.

Basic Reset and Biogenyx are prohibited from “directly or indirectly receiving, labeling, holding, or distributing dietary supplements, drugs, or devices at or from their facility until they take certain steps to ensure that all of these products comply with the law including, among other things, recalling their drugs, dietary supplements and device products, hiring qualified experts to ensure conformity with CGMP and other requirements and receiving written permission from the FDA to resume operations,” FDA said in a statement.

Source: FDA