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FDA Asks Sybaritic To Stop Unapproved Medical Device Production

Sybaritic, a medical device maker, has agreed to stop producing and distributing its medical products used in laser surgery, dermatology, and spa treatments until it is in compliance with FDA quality standards. The products are considered to be unapproved medical devices as they lack appropriate FDA clearance review and approval for safety and effectiveness.

The agreement was part of a consent decree of injunction signed by Bloomington, company and three of its top executives, Anthony Daffer, Steven Daffer, and Ronald Berglund. The consent decree was signed on Jan. 4, 2010, by US District Court Judge John Tunheim of the US District Court for the District of Minnesota, said the company.

Under the terms of the consent decree, Sybaritic agrees to comply with the FDA’s Quality System (QS) regulation for all of its devices. The company also must retain an independent expert consultant to inspect its operations and to certify to the FDA that corrections have been made.

The FDA inspections also revealed the company’s sale of numerous devices that had not undergone the required FDA premarket review as well as the company’s failure to submit medical device reports to the agency as required.

The consent decree requires the company to obtain appropriate FDA approval or clearance before it may distribute any of its devices. Once the company makes the corrective actions specified in the consent decree, it must hire an independent auditor to conduct annual inspections of all its facilities for at least four years and report the results to the FDA.

In the event of future violations at the company, the consent decree allows FDA to order the company to cease manufacturing and distributing products and to recall them. FDA can take other actions to ensure Sybaritic is compliant with FDA regulations. The company may be required to pay damages of $15,000 a day if it fails to comply with any provisions of the decree and an additional $15,000 for each violation.