Kathleen Sinninger

In 2023, Kathleen was selected as the International Inspection Liaison within FDA's Office of Inspections and Investigations (OII), where she strategically engages internal and external stakeholders on medical product issues. She was elected Chair of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) for 2026–2027, representing FDA's commitment to international regulatory cooperation and harmonization in pharmaceutical inspections. Kathleen brings over 30 years of experience with the U.S. Food and Drug Administration, having served in a range of progressive roles including Investigator, Supervisory Investigator, and Director of Investigations Branch. Early in her career, she specialized in pharmaceutical inspections — conducting foreign and domestic inspections of finished and bulk pharmaceuticals, including sterile drug processes — while also gaining broad regulatory experience across all FDA-regulated product areas, including medical devices, biologics, human foods, veterinary products, and clinical investigators