The FDA says it is not aware of any adverse events, but is advising consumers to discontinue using these products.

Sybaritic, Inc.'s attorneys have issued a public press release which states in part: "Sybaritic has signed a consent decree with the FDA to suspend selling its medical devices in the US while it works to improve its quality system processes and modify some of its claims. Sybaritic has worked cooperatively with the FDA in the past and has obtained FDA 510(k) clearances to market its medical products. Sybaritic, Inc. does not agree with the allegations in the FDA Complaint, but is cooperating with the FDA to resolve the issues raised.

Sybaritic firmly stands behind the quality of all of its products, and is dedicated to promptly resolving its record-keeping and improving its quality system documentation and processes. The FDA has acknowledged it is not aware of any adverse events concerning Sybaritic's products. Attorney Bob Klepinski of Fredrikson & Byron, who represents Sybaritic and its management team, Steven J. Daffer, Anthony S. Daffer and Ronald Berglund, is optimistic that once the FDA conducts a full and fair review of its processes, the FDA's concerns will be satisfied and that Sybaritic soon will be able to resume its U.S. sales of medical devices."

The release goes on to say that all manufacturing of exports and international sales of Sybaritic's products will continue unaffected by the consent decree, and that Sybaritic will also continue its U.S. sales of beauty, cosmetic & non-medical products.

Adapted in part from an FDA press release:
The FDA news release: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm196958.htm

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