FDA EIR - Synergy Health Concepts, Inc. - May 15, 2012

An FDA inspection of Synergy Health Concepts, Inc. in Newport Beach, CA, occurred between April 10 and May 15, 2012, as part of a review of sponsor and clinical investigator compliance. The inspection uncovered four primary issues. The company failed to submit an Investigational Device Exemption (IDE) application to the FDA for the use of certain devices in three clinical studies, which is required for significant risk studies. Additionally, there were no comprehensive accountability records for the receipt, shipment, and disposition of devices used in two of the clinical protocols. A critical finding was that informed consent for all 47 study subjects was not properly documented, as an unapproved form was used instead of the Institutional Review Board (IRB) approved versions. Finally, the firm's records for device use in one protocol were incomplete, lacking essential details such as device type, quantity, and batch or lot numbers. Following the issuance of the FDA-483 form detailing these observations, Dr. Michael A. Arata, the President and Principal Investigator, stated he would provide a written response. Management also committed to implementing a formal monitoring activity log and developing documented training records for research staff.