Other safety alerts
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| The United States: Federal judge enters consent decree against Tennessee drug, dietary supplement and device distributors, Basic Reset and Biogenyx, for drug, device and dietary supplement violations |
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The US Food and Drug Administration (FDA) announces that a federal court has ordered two Tennessee-based companies and their owner to stop distributing drugs, dietary supplements and devices until the companies comply with the Federal Food, Drug, and Cosmetic (FD&C) Act and other requirements listed in a consent decree. 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 FDA has not approved Basic Reset’s or Biogenyx’s drugs or device for any use, despite the companies’ claims that these products could be used to diagnose, cure, mitigate, treat, or prevent conditions such as inflammation, chronic diarrhea, bacterial infections, head lice, allergies and pain. Basic Reset and Biogenyx also unlawfully distributed dietary supplements that are adulterated and misbranded.
During inspections at the facility, FDA investigators found numerous violations of the CGMP requirements for dietary supplements, including failing to establish specifications to ensure that the products they receive for labeling are adequately identified and consistent with the purchase order and failing to establish and follow written procedures to review and investigate product complaints. Several of the defendants’ dietary supplements are also missing information on their labels required by law.
Please refer to the following website in FDA for details:
http://www.fda.gov/news-events/press-announcements/federal-judge-enters-consent-decree-against-tennessee-drug-dietary-supplement-and-device
In Hong Kong, there is no registered pharmaceutical product manufactured by the above companies.
Ends/Wednesday, Sep 4, 2019
Issued at HKT 16:00
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