Nichols F. Lyons, MS U.S. FDA

Nichols F. Lyons, MS

Nichols F. Lyons, MS U.S. FDA

Nicholas F. Lyons, Director of Compliance for Office of Regulatory Affairs’ Office of Pharmaceutical Products, Division III

Scholastically graduated with a M.S. degree, in science from the Illinois Institute of Technology, Chicago Illinois.

Six years of industry experience prior to joining the Agency focusing in antiviral drug research and development.

Roughly 25 years of experience with the Food & Drug Administration. Essentially, I started out as a consumer safety officer within the Chicago District Office and transitioned to management. In 2013, I had the opportunity to become the FDA import supervisor for the Port of O’Hare and the International Mail Facility.

In 2014, I became the Director of Compliance (DCB) within Chicago District and was responsible for Illinois domestic cases and all import cases through the Port of O’Hare that included the International Mail Facility. In May of 2017, I became the Director of Compliance for Pharma Division III, focusing on the pharma program area, foreign and domestic. I have been involved with numerous warning letters and judicial actions while serving as the DCB for Chicago District and the Pharma Program area. Many of these actions assisted in moving the quality of manufactured products into compliance and ensuring public health.