Venus Pharmaceuticals Shuts Down in Accordance With FDA
A dietary supplement company that allegedly failed to meet requirements set forth by the Food and Drug Administration will halt production until such time that safety can be ensured.
The company being targeted by the safety organization is the Hauppage, New York-based Venus Pharmaceuticals International. Not long ago, the FDA conducted inspections of their facility in a bid to make sure the company was adhering to current good manufacturing practices, otherwise known as cGMP. They discovered that the company was lacking in controls that could guarantee product specifications were being met.
Venus pledged to correct the issue, but when the FDA conducted a follow-up investigation, they ascertained that whatever corrections may have been taken did not bring the company into compliance with requirements. The breach in these requirements meant that any items from Venus would be considered adulterated as expressed in the Federal Food, Drug, and Cosmetic Act.
Now, Venus has come to an agreement with the FDA wherein they will cease making and distributing their supplements until they can fix their safety issues. They must alter a variety of procedures in order to come into compliance with guidelines. An auditor will be brought in to ensure this compliance over the next two years. Plus, the FDA now has the right to initiate an inspection whenever they see fit.
No one has reported becoming ill from a Venus dietary supplement at this time.