Sybaritic has decided to halt the production and distribution of its medical products used in laser surgery, dermatology, and spa treatments until it is in compliance with FDA quality standards.
The company acknowledged that its unapproved medical devices lack appropriate FDA clearance review and approval for safety and effectiveness.
FDA inspections conducted at Sybaritic have indicated that the company’s sale of numerous devices that had not undergone the required FDA premarket review.
The agreement was part of a consent decree of injunction signed by the Bloomington, Minn., company and three of its top executives, Anthony S. Daffer, Steven J. Daffer, and Ronald Berglund. 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 consent decree requires Sybaritic to obtain appropriate FDA approval or clearance before it may distribute any of its devices.
Sybaritic also must retain an independent expert consultant to inspect its operations and to certify to the FDA that corrections have been made.
In the event of future violations at Sybaritic, the consent decree allows FDA to order Sybaritic 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.
Company’s stance
“While we don’t agree with allegations in the FDA’s complaint, we are cooperating with the agency to resolve the issues raised in its complaint,” Bob Klepinski, an attorney representing Sybaritic, said in a prepared statement. “We firmly stand behind the quality of all of our products and we are committed to promptly resolving any record-keeping issues and improving our quality system documentation and processes.”
Unapproved products
The SkinBella has never been approved or cleared by the FDA. The Dermalife, NannoLight MP50, SkinClear SRVH, and the Dermosonic devices are unapproved because, although the devices have FDA clearance for marketing, Sybaritic has made claims for these devices that are not included in the FDA clearances and constitute major changes or modifications in the devices’ intended use.
Sybaritic has also made subsequent changes to some of these devices’ designs that are not included in the clearances and that could significantly impact their safety and effectiveness.
