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

This FDA Warning Letter, dated September 5, 2012, addresses objectionable conditions observed during an inspection of Synergy Health Concepts, Inc. (Synergy Health) from April 10 to May 15, 2012. The inspection evaluated Synergy Health's compliance as a sponsor of the "Venous Obstruction in Neurodegenerative Disorders Research Registry study" (Registry study) and "Radiographic and Intravascular (IVUS) Evaluation of Venous Morphology during CCSVI Treatment study" (IVUS study), and as a clinical investigator for the IVUS study. The studies involved percutaneous transluminal angioplasty balloon dilation catheters and stents, classified as significant risk investigational devices.

The FDA identified serious violations of 21 CFR Part 812 (Investigational Device Exemptions) and Part 50 (Protection of Human Subjects). As a sponsor, Synergy Health failed to submit an Investigational Device Exemption (IDE) application to the FDA and obtain FDA approval before allowing subjects to participate in the Registry and IVUS studies, involving at least (b)(4) and (b)(4) subjects respectively, for an unapproved use of significant risk devices. Additionally, Synergy Health failed to maintain accurate, complete, and current device shipment records (21 CFR 812.140(b)(2) and (d)).

As a clinical investigator, Dr. Arata failed to ensure informed consent