A New Jersey dental products manufacturer has been ordered to cease operations after an investigation by the U.S. Food and Administration (FDA) found that several of the company's products had not undergone appropriate regulatory review.
Accurate Set and the company's president and owner, Cornell Adams, have agreed to stop manufacturing and distributing certain dental products as part of a consent decree of permanent injunction.
Under the terms of the consent decree, Accurate Set must discontinue its operations until the FDA clears or approves its products, which include various restorative dental products such as dental impression and repair materials. In addition, any future manufacturing must fully comply with the FDA's quality standards.
The FDA's most recent inspection of Accurate Set, between December 2010 and January 2011, revealed significant violations of the FDA's quality system regulation, including violations related to the firm's corrective action and consumer complaint procedures, purchasing controls, and quality audits, the agency stated in a press release. The quality system regulation establishes requirements for the methods, facilities, and controls used in the production of medical devices.
Investigators also found that medical devices made by the company, such as Setacure Self Curing Polymer and Self Cure Tooth Shade Acrylic, had not undergone required FDA premarket review.
Accurate Set and Adams have represented that they are no longer manufacturing or distributing any devices. If they decide to resume operations, they first must obtain FDA approval or clearance for their medical devices.
In the event of future violations, the FDA may order Accurate Set and Adams to stop manufacturing and distributing medical devices and to recall those already on the market. The FDA can take other actions to ensure that they comply with FDA regulations, and may require Accurate Set and Adams to pay damages if they fail to satisfy the decree's provisions.
