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  1. Office of Regulatory Affairs

Who Is the ORA Ombudsman?

 

Erica M. Katherine

Erica M. Katherine is the Associate Ombudsman within ORA and has held this position since 2019. Ms. Katherine began her career at FDA in 2008 as an Investigator in the New Orleans District where she shared her time between the domestic and import programs reviewing and examining import shipments as well as performing inspections of food, drug, and medical device firms. In 2012, she became a Compliance Officer in the Florida District reviewing cases in all program areas, working on numerous workgroups, and assisting with the development of ORA procedures. In 2016, Ms. Katherine was selected as Compliance Officer of the Year for outstanding and innovative compliance work that impacted both the local and national level. Prior to joining FDA, Ms. Katherine worked in a state laboratory as a Forensic Scientist and in a private environmental testing laboratory as an Organic Chemistry Analyst. She holds a M.S. in Biotechnology, focusing on Regulatory Affairs from the University of Maryland University College, and a B.S. in Chemistry from Jackson State University.

 

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