Carla J. Lundi

Carla J. Lundi joined the FDA in 2002 as an Investigator with the Office of Regulatory Affairs in the Los Angeles District. While with ORA she was a Drug Specialist, member of the Pharmaceutical Inspectorate, and member of the Drug Foreign Inspection Cadre specializing in sterile drug manufacturing inspections. In 2016, she transferred to CDER’s Office of Pharmaceutical Quality, Office of Quality Surveillance working primarily on monitoring drug manufacturing site and product quality-related signals for mitigation of significant public health issues; evaluation and reporting of data related to pharmaceutical quality and drug availability for internal business partners and external stakeholders; collaborating with business partners to develop meaningful and innovative surveillance approaches that facilitate data driven and risk-based decision making; and drug investigator training collaboration and development.