The Food and Drug Administration says a court order against Accurate Set
requires the company to discontinue operations until the agency has
verified its dental implants meet federal standards.
Accurate Set Inc., of Newark, N.J., 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.
Under the terms of the consent decree, Accurate Set
must discontinue its operations until the U. S. Food and Drug
Administration 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.
The FDA’s most recent
inspection of Accurate Set, between December 2010 and January 2011,
revealed significant violations of the FDA’s Quality System (QS)
regulation, including violations related to the firm’s corrective action
and consumer complaint procedures, purchasing controls, and quality
audits. The QS 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. The consent decree
also requires them to comply with the QS regulation for all their
devices and to retain an independent expert to inspect their operations
and certify to the FDA that the necessary corrections have been made.
“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.
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.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm291648.htm
