October 26, 2012
NEW YORK Venus Pharmaceuticals International Inc. and its top executive Bharat Kakumanu have agreed to stop production and distribution of dietary supplements into U.S. commerce under a consent decree that a federal judge signed earlier this month, the consequence of repeated violations of current good manufacturing practice (cGMP) regulations, FDA announced Thursday.
The company also has agreed to recall and destroy product that was produced before January 2012, and Hauppauge, N.Y.-based Venus is barred from exporting products unless its activity complies with FDA laws and regulations, the government agency revealed.
Under the consent decree, before it can resume production of dietary supplements, the company must implement corrective actions that include changing procedures for labeling, manufacturing and packaging dietary supplements. Venus also must hire an outside auditor to monitor the changes and the auditor must send reports to the FDA in connection with the company's compliance.
FDA also has right under the decree to inspect Venus's facilities at any time and order the company back into compliance with regulations.
During inspections of the company's facilities, FDA noted Venus failed to have controls in place to verify its final products satisfied established specifications. Kakumanu, the chief executive of Venus, received a warning letter 17 months ago for violations of regulations.
Still, FDA noted that no illnesses have been linked to Venus's products.
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