Cathy L. Burgess

Cathy Burgess leads the firm’s FDA Compliance and Enforcement Team and FDA practice. FDA-regulated entities benefit from Cathy's common-sense advice for achieving business objectives that avoid compliance and enforcement risks. With more than 30 years of extensive experience in the areas of CGMP regulation and product risk management, she provides strategic counseling and works with clients to identify and address potential risks throughout the product life cycle. Cathy 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 and supply chain management. 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. She advises clients on quality system remediation, inspection management, recalls, and responses to Form FDA 483s and warning letters. Cathy also conducts whistleblower investigations, special audits, and due diligence reviews related to FDA compliance. She assists clients in designing compliance programs, internal audit programs, and other risk mitigation strategies. Cathy is a recipient of the FDLI 2023 Distinguished Service and Leadership Award. Before joining Alston & Bird, Cathy served as associate general counsel for the American Red Cross, where she was responsible for regulatory matters.

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