Accurate Set Inc (Newark, NJ), and the company's president and owner, Cornell L. Adams, have agreed to stop manufacturing and distributing medical devices as part of a consent decree of permanent injunction. No Web site could be found for the company.
According to FDA, under the terms of the consent decree, Accurate Set must discontinue its operations until FDA clears or approves its products, which include a variety of 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 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, in a press release.
According to the agency, its most recent inspection of the company was between December 2010 and January 2011. The inspection revealed significant violations of FDA's Quality System Regulation (QSR), including violations related to the firm's corrective action and consumer complaint procedures, purchasing controls, and quality audits. The QSR establishes requirements for the methods, facilities, and controls used in the production of medical devices. Warning letters were sent in October 2003 and April 2010.
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.
FDA says that 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. The consent decree also requires them to comply with the QRS for all of their devices and to retain an independent expert to inspect their operations and certify to FDA that the necessary corrections have been made.
In the event of future violations, FDA may order Accurate Set and Adams to stop manufacturing and distributing medical devices and to recall those already on the market. FDA can also take other actions to ensure that the company complies with FDA regulations, and it may require Accurate Set and Adams to pay damages if they fail to satisfy the decree's provisions.
The consent decree was signed by Judge Susan D. Wigenton of the US District Court for the District of New Jersey on February 9, 2012.
FDA advises healthcare providers to discontinue using these products and to contact the firm for more information. Any complaints of adverse events should be reported to the agency.