Venus Pharmaceuticals International Inc., of Hauppauge, N.Y., and Bharat Kakumanu, its chief executive officer, have agreed to stop production and distribution of dietary supplements into U.S. commerce and recall and destroy affected product produced prior to January 2012, due to repeated violations of current good manufacturing practice (cGMP) regulations. In addition, the firm is prohibited from exporting products unless such activity is in compliance with FDA laws and regulations.
U.S. District Judge Arthur D. Spatt of the U.S. District Court for the Eastern District of New York signed the consent decree on October 15, 2012.
During inspections of the firm, FDA investigators noted that, among other violations, the company did not have controls in place to ensure its final products met established specifications. Following these violative inspections, the company committed to implementing immediate corrective actions.
Follow-up inspections revealed that the firm failed to take adequate corrective action to ensure the manufacturing process complied with cGMP requirements. Failure to follow cGMP requirements made Venus Pharmaceuticals’ products adulterated under the Federal Food, Drug, and Cosmetic Act.
“When a company violates public health protections, they put consumers at risk,” said Melinda K. Plaisier, acting associate commissioner for regulatory affairs. “Our goal at the FDA is to ensure that consumers have access to dietary supplements that meet good manufacturing practices, so that the products do not harm consumers.”
As part of the consent decree, the company must implement a series of corrective actions before it can resume production of dietary supplements. The actions include changing procedures for manufacturing, packaging, and labeling dietary supplements so that they meet FDA requirements.
In addition, the company must hire an outside auditor to oversee and review progress in implementing the needed changes. For the next two years, the auditor must send quarterly reports to the FDA concerning the company’s progress with compliance, and additional reports every six months, thereafter. Venus Pharmaceuticals will be held to strict compliance deadlines for implementing the changes identified in the auditor’s reports.
According to the decree, the FDA may inspect the company’s operations at any time and order measures needed to bring the company back into compliance with the FDA’s cGMP requirements and other applicable regulations.
To date, no illnesses have been associated with Venus Pharmaceuticals International products. Any illnesses or adverse events related to use of these products should be reported to the FDA at [email protected] or by calling 800-322-1088.