Drawing from over 15 years of experience working in FDA’s Office of Chief Counsel and private practice, Deepti Kulkarni provides strategic advice to clients on a wide range of matters involving FDA and USDA regulatory oversight of foods, dietary supplements, and animal health products. She works closely with clients to develop and execute strategies to satisfy regulatory requirements and mitigate enforcement and litigation risk while also meeting key commercial goals.
Deepti also counsels clients on potential crises, such as product recalls, import refusals, and responding to agency warning or noncompliance letters, adverse inspection findings and other regulatory actions.
Chambers USA reports that Deepti is “a very strategic lawyer with deep expertise and strong business acumen,” “a food law and regulation expert,” who “has an incredibly thorough grasp of the regulatory process,” finds “creative solutions to novel and complex issues,” and “is also very responsive and gives sound and practical advice.”
Deepti previously served as an Associate Chief Counsel in FDA’s Office of Chief Counsel. While at FDA, she counseled various components of FDA and HHS on a broad scope of issues related to foods, dietary supplements, cosmetics, and animal health products as well as cross-product matters involving imports and exports, advisory committees, and constitutional issues. She also played a key role in the development and implementation of regulatory frameworks for foods and other products developed using biotechnology, gene editing, and other new and emerging technologies. Deepti received several awards during her time at the FDA, including the FDA Award of Merit (FDA’s highest award), Commissioner’s Special Recognition Award, and the CFSAN Director’s Special Citation Award.
Deepti also serves as an Adjunct Professor of Law at Georgetown Law School where she teaches Food and Drug Law.
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