New Jersey Company Halts Production of Unapproved Dental Devices

New Jersey Company Halts Production of Unapproved Dental DevicesA medical device manufacturer based in New Jersey has agreed to stop production of its products due to pressure from the Food and Drug Administration (FDA).

On Monday, February 13, Accurate Set Inc., of Newark, N.J., and the company’s president and owner, Cornell L. Adams, announced the company would stop producing and distributing select medical devices pursuant to a consent decree of permanent injunction.

The decree stated that Accurate Set must cease production of the device until the U.S. Food and Drug Administration either clears or approves the currently untested products, which include several dental devices such as dental impression and repair materials. Also, the decree stipulates any future manufacturing must comply in full with the FDA's quality standards.

"The FDA has very clear requirements for the clearance, approval, and production of medical devices," said Steven Silverman, director of the Office of Compliance in the FDA’s Center for Devices and Radiological Health.

Between December 2010 and January 2011, the FDA's inspection of Accurate Set revealed significant violations of the FDA Quality System (QS) regulation, including violations regarding the company's corrective action and consumer complaint procedures, purchasing controls and quality audits. QS regulation was developed to create requirements the methods, facilities and controls used in the manufacturing of medical devices.

"This consent decree demonstrates the FDA’s commitment to protecting the public health from the dangers of unapproved and improperly manufactured medical devices," said Dara A. Corrigan, associate commissioner for regulatory affairs.

If the company is found to violate FDA regulations again, the agency will have the right to stop all manufacturing and distribution of its medical devices, and potentially recall those that have been sold. If Accurate fails to comply with the decree's provisions, they could be forced to pay damages.