Barbara Wilimczyk-Macri MS U.S. FDA

Barbara Wilimczyk-Macri has been with the United States Food & Drug Administration (FDA) since 2009. She started as an Investigator and in 2014 became an Investigator, Drug Specialist. In those roles, she conducted pharmaceutical inspections of both domestic and international active pharmaceutical ingredient (API) and finished drug manufacturers. In 2016, she became a Compliance Officer within the New Jersey District and in 2017, a Compliance Officer within ORA, Office of Pharmaceutical Quality Operations (OPQO), Division I. In 2020, she became a Senior Compliance Officer within the Office of Pharmaceutical Quality Operations, Division I. As such she reviews, evaluates and prepares proposed legal actions and makes recommendations for regulatory action based on findings of non-compliance. She has received a Bachelor of Science, Biological Sciences, and a Master of Science, Microbiology and Molecular Genetics, from Rutgers University. Prior to joining the Agency, she was employed in roles pertaining to Microbiology within the Pharmaceutical and Biologics Industry.