George M. Karavetsos

How George Helps Clients

George provides strategic advice to Food and Drug Administration (FDA) regulated companies. He navigates clients through the various stages of a product’s life cycle, from clinical trials and premarket development, advertising and promotional compliance, good manufacturing practices to minimizing postmarket enforcement and litigation risks. Having the unique combination of experience as a former regulatory attorney with the FDA, federal prosecutor, and director of FDA’s Office of Criminal Investigations, George brings clients a rare perspective which assists clients achieve exceptional results in highly complex regulatory matters, and high-stakes civil, criminal, and corporate litigation.

FDA Regulatory & Compliance

George spent five years at the FDA, first as an assistant chief counsel in FDA’s Office of the Chief Counsel, where he worked on complex civil regulatory and compliance and criminal enforcement matters involving the Federal Food, Drug, and Cosmetic Act (FDCA), and then as the director of FDA’s Office of Criminal Investigations. As director, he led more than 300 federal law enforcement agents and was responsible for establishing FDA’s criminal investigative priorities which focused on activities involving pharmaceutical, biologics, and medical device companies and distributors, food manufacturers and distributors, dietary supplement manufacturers, and tobacco companies.

George regularly counsels pharmaceutical, biotechnology, medical device, and diagnostic companies, including start-up companies, regarding the regulatory and compliance requirements related to the development, approval, and marketing of FDA regulated products. He also has extensive experience in conducting due diligence and related counseling in connection with financing, mergers, and acquisitions involving the life sciences and health care industries.

Litigation & Investigations

George is a highly experienced and skilled trial attorney. He served as an assistant U.S. attorney in the Southern District of Florida for over 12 years, where he successfully tried many high profile cases involving healthcare fraud, violations of the FDCA, international narcotics trafficking and money laundering, robbery, and firearms offenses. In addition to being the Chief of the Narcotics Section in the U.S. Attorney’s Office, he also rose to the position of executive assistant U.S. attorney, the third-highest ranking position in the District. He also served as an Assistant District Attorney in Massachusetts where he tried hundreds of cases. 

George has extensive experience responding to product and compliance related government initiated civil and criminal investigations as well as leading internal investigations on behalf of companies. He counsels and defends clients on matters involving allegations of healthcare fraud and abuse, the Anti-Kickback Statue, False Claims Act, the Foreign Corrupt Practices Act, government contract fraud, and money laundering.

What Clients Can Expect

George’s clients appreciate his insider’s perspective of what to expect from the FDA or Department of Justice (DOJ) because of the high level, decision making, positions in which he served in at the FDA as well as the U. S. Attorney’s Office, and they put their trust in him to strategically guide them every step of the way through highly complex regulatory, compliance, and civil and criminal enforcement matters.

My unique combination of experience as an assistant chief counsel at FDA, federal prosecutor, and director of FDA’s Office of Criminal Investigations distinguishes me from any other attorney in the United States. No other attorney has this rare combination of FDA regulatory, compliance, enforcement and federal criminal trial experience.

Outside the Office

George and his wife are the proud parents of four young children and enjoy spending time going on bike rides, going to the beach, skiing, and fishing with them. On most weekends you will find George and his family at either a baseball, soccer, or flag football field.

Proof Points

• Provided strategic advice and successfully counseled a national electronics company through FDA’s Emergency Use Authorization (EUA) process which led the company to receive an EUA to market and distribute ventilators in an effort to assist in the fight against COVID-19.
• Successfully led an independent regulatory compliance review of a national spring water company and confirmed that the company’s labeling and marketing of its product as spring water was consistent with FDA’s definition of spring water under the Code of Federal Regulations.
• Successfully led an internal compliance review of a pharmacy’s compliance program and its opioid prescribing practices in response to DOJ, DEA, and State Attorney General’s investigations which led to a civil settlement and no criminal charged filed against the company.
• Provided counsel and successfully led an internal investigation of an international pharmaceutical distributor in response to a federal criminal investigation which led to no charges being filed against the company.
• Provided counsel and led the voluntary recall of a product on behalf of a pharmaceutical manufacturer which led to no regulatory actions being brought against the company.

Awards

• Recognized on The Best Lawyers in America^© list in the Criminal Defense: White Collar category - 2024
• Recipient of Cystic Fibrosis Foundation’s 2nd Annual 40 under 40 Outstanding Lawyers of Miami-Dade County - 2010
• Recipient of the United States Coast Guard’s Meritorious Public Service Award - 2009
• Recognized by FBI Director Robert S. Mueller for the Prosecution of a Drug Kingpin - 2008