Chris Middendorf

Experience

Chris has over two decades of experience at FDA. A former Drug Specialist in ORA Chris was assigned the most difficult drug inspections within the U.S. and internationally. He served 3.5 years as a Diplomat and Assistant Country Director for Drugs at FDA’s China Office and served as a Diplomat and International Policy Advisor at FDA’s India Office. His last role at FDA was Senior Policy Advisor in the Office of Compliance at CDER. Since leaving FDA, Chris worked as the Director of Regulatory Affairs and GMP Compliance at Hogan Lovells where he specialized in remediating FDA enforcement actions. 

Expertise

Chris’ FDA experience included time as an instructor at FDA’s Basic Drug School. Chris’ inspections have resulted in injunctions, Warning Letter, application withholds and recalls. While in CDER’s Office of Compliance, Chris served as the aseptic processing and data integrity subject matter expert and provided compliance policy consultation to drug review offices and CDER Compliance officers when clear compliance policy did not exist. 
Since leaving FDA, Chris has focused on preventing enforcement actions by assisting clients in developing Corrective Action Plans and responding to FDA 483s. He also has extensive experience in remediating compliance actions including, leading investigations and CAPAs for clients and developing return-to-operation plans. Chris also assisted large complex organizations in optimizing and implementing Global Quality Management systems.

Education

B.S. Biology University of Cincinnati, M.S. Animal Science, Auburn University