About George
With over two decades of distinguished service in federal criminal investigations and a unique combination of legal expertise and regulatory knowledge, George brings unparalleled experience to corporate investigations and compliance consulting. His investigative career spans 24 years in criminal investigations, with the last 16 years dedicated to serving with the FDA's Office of Criminal Investigations. In this capacity, he led and managed sophisticated investigations into violations of the federal Food, Drug and Cosmetic Act, developing deep expertise in the intricate regulatory framework governing life sciences companies. His work involved investigating complex schemes involving pharmaceutical fraud, medical device violations, and other critical public health matters that required both technical understanding and investigative acumen. Among his most significant achievements was serving as the lead FDA case agent in the landmark Theranos investigations and prosecutions of Elizabeth Holmes and Ramesh "Sunny" Balwani. This high-profile case demonstrated his ability to navigate complex corporate structures, analyze sophisticated scientific claims, and coordinate multi-agency investigations involving cutting-edge biotechnology. His investigative portfolio includes numerous high-profile criminal investigations into life sciences firms, where he developed expertise in understanding complex corporate governance structures, identifying compliance failures, and working with corporate counsel to navigate regulatory requirements.
During his tenure as leader of FDA's Metro Washington Field Office, he held responsibility for reviewing, analyzing, and designating for assignment every False Claims Act complaint involving FDA-regulated products. This role required regular consultation with FDA agency attorneys, Department of Justice attorneys, and senior regulatory officials, providing him with comprehensive insight into the decision-making processes that govern federal enforcement actions. This experience afforded him a unique perspective on how regulatory agencies prioritize cases, assess risk, and develop enforcement strategies, while equipping him with a rare skill set that bridges the gap between regulatory compliance and legal strategy.
Now, as he transitions to the private sector, he is establishing a company focused on providing corporate investigative support to law firms and internal investigations and consulting services to life sciences companies. His approach to corporate investigations and compliance consulting is informed by deep understanding of how federal agencies conduct investigations, what triggers enforcement actions, and how companies can best position themselves to avoid regulatory scrutiny while maintaining operational efficiency. Having earned his Juris Doctor from Case Western Reserve University School of Law and a Bachelor of Science in Organizational Behavior from Miami University, his extensive FDA experience combined with his legal education provides a distinctive advantage in understanding both the regulatory landscape and the legal implications of corporate decision-making in the life sciences industry.
Education
Case Western Reserve University School of Law
JD, 2000
Miami University
BS, Organizational Behavior, 1997
Ohio Bar License: #0073083