Federal judge enters consent against Tennessee drug, dietary supplement and device distributors, Basic Reset and Biogenyx for drug, device, and dietary supplement violations.

A federal judge in Tennessee ordered a consent decree of permanent injunctions against two Tennessee-based companies, Basic Reset and Biogenyx. The permanent injunction prohibits the two companies and their owners from distributing unapproved new drugs, adulterated and misbranded dietary supplements and an adulterated and misbranded device due to noncompliance with the FD&C Act.

The FDA has not approved Basic Reset or Biogenyx’s drugs (or devices), despite the companies’ claims that these products are intended for use as a drug and can be used to diagnose, cure, or treat certain conditions. After several inspections at the facility, FDA investigators found the companies to be in violation of multiple cGMP requirements including failing to establish specific procedures 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. These violations caused their dietary supplements to be labeled as adulterated. According to a warning letter issued in 2016, the companies failed to establish and follow written procedures for quality control operations that are necessary to ensure the quality of the dietary supplements being produced. Several dietary supplements were also found to be misbranded because they were missing required information on their labels. A device that was adulterated and misbranded was also distributed by the companies.

After several inspections at both facilities between 2012 and 2017, and a failure to make the necessary corrections for the companies’ violations highlighted in a warning letter to the companies in 2016, a consent decree of permanent injunction was entered against Basic Reset and Biogenyx and its owners. Although the FDA identified specific actions that can be taken for the companies to establish packaging and labeling as well as documentation of distribution specifications, the companies failed to provide any evidence of corrective action in follow-up inspections. The FDA emphasized its commitment to taking action when unapproved, misbranded and adulterated products enter the marketplace, putting consumers at risk.

mdi Consultants has been involved with many clients on various projects dealing with FDA inspections, audits, cGMP compliance and potential violations pertaining to the FD&C Act. If would like to discuss this case and/or you need any assistance with product quality, safety, cGMP or other FDA regulations, please contact us for a free consultation.

We have found that the issuance of FDA warning letters is on the rise and the FDA is AGAIN taking regulatory compliance SERIOUSLY. What needs to be understood is that the FDA will do follow-ups and check up on facilities once warning letters have been issued therefore, if a warning letter has been issued against your product, it is imperative you seek corrective action immediately to prevent legal action in the future. A PLAN to ACHIEVE compliance is imperative. You need to know how to work with the AGENCY. mdi’s 41 years of FDA consulting can provide you this experience to address the FDA concerns.

We will continue to monitor any updates pertaining to the consent decree moving forward. If you have any questions about warning letters, inspections, cGMP regulations and the FDA, how this can affect your company, or for any of your regulatory requirements feel free to contact us at [email protected] or use our contact form.