FDA: Sybaritic Must Stop Producing Unapproved Medical Devices

Until they're in compliance with FDA quality standards, Sybaritic, Inc., a medical device manufacturer, has agreed to stop producing its products manufactured for use in laser surgery, dermatology and spa treatments.

According to a press release from the FDA, these products are considered to be unapproved medical devices because they lack the appropriate FDA clearance and approval for safety and effectiveness.

Under the terms of their consent decree with the FDA, Sybaritic agreed to comply with the FDA's Quality System (QS) regulation and retain an independent expert consultant to inspect its operations and certify to the FDA that corrections have been made.

Over the past several years, the FDA has conducted inspections at Sybaritic that revealed violations of the QS regulation, including violations related to design controls, complaint handling, corrective and preventive action and quality audits. These inspections also revealed that a number of Sybaritic products had not undergone the required FDA premarket review. The company also failed to submit medical device reports to the FDA as required.