Cathy Burgess

  PhotoCathy Burgess is a Washington, D.C. partner in the firm’s Health Care Group. Her practice focuses on regulatory compliance, product risk management, enforcement and policy matters affecting industries regulated by the Food and Drug Administration (FDA). Prior to joining the firm, Cathy served as associate general counsel for the American Red Cross, responsible for regulatory matters. In this role she provided legal assistance and strategic advice to Red Cross senior management and the Board of Governors' Audit Committee on matters related to the Red Cross Amended Consent Decree. She advises clients on a range of matters affecting prescription and OTC drugs, biologics, medical devices, foods and cosmetics, and has extensive experience regarding current good manufacturing practice (CGMP) regulation. For products regulated under the Federal Food Drug and Cosmetic Act (FDCA), Cathy conducts liability risk assessments and works with clients to identify and analyze potential legal risks associated with their products throughout the product life cycle. She advises clients on quality systems, adequacy of SOPs, investigation reports, inspection management, recalls and responses to Form FDA 483s and Warning Letters. Cathy also conducts internal investigations and special audits related to FDA compliance and assists clients in designing compliance programs, internal audit programs and other risk mitigation strategies.