U.S. regulators have shut down a dental medical device manufacturer over violating regulations governing quality service protocol.
The U.S. Food and Drug Administration found that some of the company’s medical devices had not undergone required FDA premarket review.
The violations also include the medical device company’s consumer complaint procedures for purchasing controls and quality audits.
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Accurate Set in Newark, New Jersey, along with Cornell L. Adams, the company’s president and owner, agreed to stop manufacturing and distributing medical devices as part of a consent decree of permanent injunction, signed by a New Jersey District Court judge.
The company had previously received two warning letters in 2003 and 2010.
The FDA has been toughening its stance on violators, using legal channels to enforce compliance from companies like Ranbaxy and Johnson & Johnson (NYSE: JNJ) to punishing company directors with fines and prison time such as with Synthes.
