L. Scott Donnelly, PhD

Dr. L. Scott Donnelly, PhD, is among the most skilled food science safety experts in the United States. He provides professional technical services to The Food Lawyers® in the areas of food manufacturing safety, Ready-To-Eat compliance as defined by FDA regulations and food facility Hazard Analysis Critical Control Point (“HACCP”) compliance.

Dr. Donnelly holds a Ph.D. in Food Science from the University of Minnesota,Minneapolis, an M.S. in Bacteriology from Iowa State University, Ames, Iowa, and a B.A. in Biology and English from St. Olaf College, Northfield, Minnesota.

Dr. Donnelly is the former Director of Product Safety of Wyeth Pharmaceuticals’ Nutritional Business Unit. Prior to this, he was Wyeth’s Director of Product Safety responsible for working proactively with Wyeth Global Nutrition respecting powdered infant formula and other products’ production in Mexico, Ireland, Singapore, Philippines, and China. In that position, he ensured the manufacture of safe and compliant products meeting all applicable quality standards.

Additionally, Dr. Donnelly provided strategic direction to Wyeth’s manufacturing sites for the control and containment of microorganisms and the development, implementation and qualification of new analytical and microbiological testing methods. He also led task groups to investigate and avoid product safety problems and to respond to compliance incidents while also developing and conducting technical training for site personnel, including HACCP training. Dr. Donnelly retired from Wyeth in 2007.

Since 2008, Dr. Donnelly has audited over 300 factories in the U.S., Canada, and South Africa as a food safety consultant and worked with seafood operations in Canada and Honduras to remove them from the FDA’s Detention Without Physical Examination List (“Red List”). In addition, he has made multiple trips to Asia to assess factories for safe powdered infant formula manufacture.

Dr. Donnelly holds PCQI (Preventive Controls Qualified Individual) certification respecting the federal Food Safety Modernization Act as a lead instructor. He completed High Risk Safe Quality Foods Consultant certification and is HACCP certified. Also, Dr. Donnelly has served as an expert witness in litigation in federal and state court and in commercial arbitrations.

Dr. Donnelly applies his remarkable background in food safety and technology to The Food Lawyers’® clients’ benefit in both litigation and regulatory matters.