Tracie H. Sharp, MHA U.S. FDA

Tracie H. Sharp joined the FDA in 2012 as a Consumer Safety Officer in CDER’s Office of Compliance, Office of Manufacturing Product Quality, Division of Good Manufacturing Practice Assessment, where she evaluated facilities drug production capabilities, testing abilities, and scale-up activities and determined inspectional priorities related to New Drug Applications (NDAs)/Abbreviated New Drug Applications (ANDAs).

In 2015, Tracie moved to CDER’s Office of Pharmaceutical Quality, Office of Process and Facilities, Division of Inspectional Assessment as a Facility Reviewer, where she continued to use risk-based approaches for efficient assessment of manufacturing facilities, processes and controls for certain drug substances and intermediates, and for all ANDA and NDA drug products. Shortly thereafter, Tracie returned to CDER’s Office of Compliance, Office of Manufacturing Quality (OMQ), Division of Drug Quality where she assessed potential compliance and enforcement actions based on the review and analysis of evidence of adulteration-based deficiencies, considering compliance policy and public health risks for application and non-application drug products. After four years as a Team Leader, Tracie moved on to become a Branch Chief within OMQ in 2020.

Tracie holds a Bachelor of Science degree from Coppin State University and a Master of Health Administration degree from the University of Phoenix.