FDA WARNING_LETTER - John Joseph Hewett, M.D. - May 15, 2012

The FDA issued a Warning Letter to Dr. John Joseph Hewett of Synergy Health Concepts, Inc. following an inspection from March 23 to May 15, 2012. The inspection assessed compliance with federal regulations for the "Venous Obstruction in Neurodegenerative Disorders Research Registry Study" (Registry study) and "Venous Irregularities, Flow and Perfusion in MS Study" (VERIFY MS study), which involve investigational medical devices (percutaneous transluminal angioplasty balloon dilation catheters and stents).

The letter identified serious violations of 21 CFR Part 812 (Investigational Device Exemptions) and Part 50 (Protection of Human Subjects). Key violations include: 1. **Failure to conduct investigations according to the plan (21 CFR 812.100):** Dr. Hewett failed to check pre-procedure creatinine levels in at least (b)(4) VERIFY MS subjects, despite the protocol requiring it to prevent MRI contrast agent complications in subjects with creatinine levels >1.8 mg/dl. 2. **Failure to obtain proper informed consent (21 CFR 50.27(a)):** At least (b)(4) VERIFY MS subjects signed an unapproved consent form. For the Registry study, an unapproved form was used for at least (b)(4) subjects from July 27 to December 27,