Taking Down Theranos with George A. Scavdis

Tuesday, October 14th, 2025
4:30 PM - 5:30 PM

Add to Calendar: Add to Calendar: 2025-10-14 16:30:00 2025-10-14 17:30:00 Taking Down Theranos with George A. Scavdis Event Description Join us for an exclusive talk with George Scavdis, the lead FDA investigator and CWRU School of Law alumnus who prosecuted Theranos. In 2018, the world watched as a $9 billion company, once hailed as a medical breakthrough, crumbled into one of the biggest corporate fraud cases in history. What really happened behind the closed doors of Theranos? And how did a company with such a powerful vision go so wrong? George Scavdis, a former special agent for the FDA's Office of Criminal Investigations, was the man on the inside. He'll take us beyond the headlines and into the heart of the investigation, sharing firsthand insights into the compliance failures that led to the downfall of Elizabeth Holmes and Sunny Balwani. Drawing on his 22-year career prosecuting complex fraud cases—from medical device companies to healthcare schemes—Scavdis will reveal how organizations often stumble not from malicious intent, but from a lack of oversight, poor communication and gaps in regulatory understanding. This isn't just a story about a sensational crime; it's a powerful lesson in prevention. Scavdis will share how his experience with real cases and real consequences led him to a new mission: helping companies build stronger compliance systems before they find themselves in the crosshairs of federal law enforcement. Don't miss this rare opportunity to learn from the investigator who witnessed it all. Speaker Biography After earning his J.D. in 2000, George Scavdis found himself drawn to federal law enforcement, eventually joining the FDA's Office of Criminal Investigations in 2009. Over 16 years with the FDA, Scavdis investigated some of the agency's most complex cases. His career culminated as special agent in charge of the FDA's Metro Washington Field Office, managing 30 employees across eight states and personally reviewing every False Claims Act complaint involving FDA-regulated products in his jurisdiction. After spending 16 years investigating companies after problems had occurred, Scavdis began questioning whether there was a better way. Could his investigative skills and regulatory knowledge help companies before they found themselves in regulatory crosshairs? That question led him to establish The Scavdis Group, where he now works with life sciences companies and law firms to strengthen compliance systems and conduct internal investigations. His speaking engagements—from his alma mater's Compliance Risk Management Institute to the Association of Medical Device Manufacturers meetings—reflect this evolution from enforcement to prevention, bringing perspectives grounded in real cases, real consequences and real solutions. Scavdis holds a Bachelor of Science in Organizational Behavior from Miami University. Through The Scavdis Group, he continues bridging the gap between enforcement and prevention, helping organizations protect both their business and the people they serve. Moot Court Room School of Law School of Law America/New_York public

1.0 hour of CLE credit has been approved

Event Description

Join us for an exclusive talk with George Scavdis, the lead FDA investigator and CWRU School of Law alumnus who prosecuted Theranos.

In 2018, the world watched as a $9 billion company, once hailed as a medical breakthrough, crumbled into one of the biggest corporate fraud cases in history. What really happened behind the closed doors of Theranos? And how did a company with such a powerful vision go so wrong?

George Scavdis, a former special agent for the FDA's Office of Criminal Investigations, was the man on the inside. He'll take us beyond the headlines and into the heart of the investigation, sharing firsthand insights into the compliance failures that led to the downfall of Elizabeth Holmes and Sunny Balwani.

Drawing on his 22-year career prosecuting complex fraud cases—from medical device companies to healthcare schemes—Scavdis will reveal how organizations often stumble not from malicious intent, but from a lack of oversight, poor communication and gaps in regulatory understanding.

This isn't just a story about a sensational crime; it's a powerful lesson in prevention. Scavdis will share how his experience with real cases and real consequences led him to a new mission: helping companies build stronger compliance systems before they find themselves in the crosshairs of federal law enforcement.

Don't miss this rare opportunity to learn from the investigator who witnessed it all.

Speaker Biography

After earning his J.D. in 2000, George Scavdis found himself drawn to federal law enforcement, eventually joining the FDA's Office of Criminal Investigations in 2009. Over 16 years with the FDA, Scavdis investigated some of the agency's most complex cases. His career culminated as special agent in charge of the FDA's Metro Washington Field Office, managing 30 employees across eight states and personally reviewing every False Claims Act complaint involving FDA-regulated products in his jurisdiction.

After spending 16 years investigating companies after problems had occurred, Scavdis began questioning whether there was a better way. Could his investigative skills and regulatory knowledge help companies before they found themselves in regulatory crosshairs? That question led him to establish The Scavdis Group, where he now works with life sciences companies and law firms to strengthen compliance systems and conduct internal investigations.

His speaking engagements—from his alma mater's Compliance Risk Management Institute to the Association of Medical Device Manufacturers meetings—reflect this evolution from enforcement to prevention, bringing perspectives grounded in real cases, real consequences and real solutions. Scavdis holds a Bachelor of Science in Organizational Behavior from Miami University. Through The Scavdis Group, he continues bridging the gap between enforcement and prevention, helping organizations protect both their business and the people they serve.

Event Location

Moot Court Room

Headshot of George Scavdis