Brendan Carroll

Compliance and Enforcement

• Prepared for and managed FDA inspections in the U.S., Europe, India, and China.
• Assisted manufacturing facilities navigating “Official Action Indicated” status, lift Warning Letters, resolve Import Alerts, address agency Requests for Information and close out inspections.
• Advised on FDA enforcement action related to changes to the design of a medical device against FDA-approved specifications and applications.
• Managed major data integrity investigations, including one spanning 10 years.
• Represented clients in front of the FDA and participated in regulatory meetings involving key Center for Drug Evaluation and Research officials within the FDA’s Office of Compliance, Office of Regulatory Affairs, Office of Chief Counsel, and Office of Pharmaceutical Quality.
• Expert FDA witness in a Court of International Arbitration proceeding, which led to the dismissal of a multimillion-dollar lawsuit involving the FDA’s Emergency Use Authorization (EUA).
• Drafted complaints letters to the FDA containing allegations of regulatory misconduct.
• Negotiated a memorandum of agreement with the Department of Justice and the Drug Enforcement Administration on behalf of a pharmacy handling controlled substances.
• Negotiated a settlement agreement with the Alcohol and Tobacco Tax and Trade Bureau action against an alcohol distributor.

Brendan Carroll represents a variety of industry stakeholders engaged in the design and development, manufacture, sale, and distribution of a wide range of FDA-regulated products. General counsel come to Brendan to help them find practical solutions to highly scientific and technical product and manufacturing.

For two decades, Brendan has represented the life sciences industry, focusing his practice on FDA regulatory, compliance, and enforcement matters. After starting his career working on one of the largest drug product liability matters to date, for Wyeth (now Pfizer), Brendan helps clients navigate the dense and ever-changing FDA legal landscape for drugs, devices, and other FDA-regulated products.

When significant compliance and enforcement matters stemming from FDA inspections arise, Brendan regularly travels to client locations to provide hands-on solutions and practical advice catered to each client’s facility and business needs. Brendan also tackles the nuanced intersection of the FDA with other regulatory agencies, including the Drug Enforcement Administration, U.S. Department of Agriculture, Alcohol and Tobacco Tax and Trade Bureau, and Customs and Border Protection.

Chambers USA: America’s Leading Lawyers for Business identified Brendan in their annual rankings for Healthcare: Pharmaceutical/Medical Products Regulatory. He is also recognized by The Best Lawyers in America^® in FDA Law.

Bar Admissions

• District of Columbia
• Maryland

Education

• American University (J.D., 2011)
• Princeton University (B.A., 2006)

Memberships