Accurate Set, Dental Products Company, Shut Down By FDA

WASHINGTON -- Federal health officials say a New Jersey company has been legally barred from making and selling a variety of dental products due to violations at its manufacturing facility.

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.

FDA inspectors found numerous quality control violations at the company's factory in Newark, N.J., during a recent inspection. The company did not have systems in place for reviewing customer complaints or correcting defective products, among other missing requirements.

The company is not currently manufacturing devices and will have to pass an FDA review process before resuming operations.

A consent decree between the company and the FDA was signed by a judge last Thursday.

Also on HuffPost:

Comments

[Jesse EngAmer]

05:03 PM on 02/13/2012

Once in a while the FDA gets it right. It sounds like they got it right here. The FDA found and eliminated a potential danger to consumers. Even better, they didn't permanently destroy a business in a time when jobs are so important. They're giving the company the chance to resume operations. Well played FDA. Too often this isn't typical of FDA regulations. Sometimes, its just pointless regulation, like FDA regulation on dietary supplements. Check out this article by Michelle Minton at CEI: http://bit.ly/xVBZ4v