Monday, February 13, 2012

Food and Drug Administration Shuts Down Dental Implant Manufacturer

Accurate Set must discontinue operations.

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 was signed by the company last Thursday.

Here are the warning letters on the FDA website.

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