Christopher (Chris) Middendorf

Chris’ primary focus is preventing and remediating FDA enforcement actions – especially within aseptic manufacturing environments. Chris places an emphasis on prevention as the best strategy for avoiding regulatory issues. He routinely advises clients on FDA manufacturing regulatory strategies. He supports clients in communicating with FDA, increasing quality maturity, upskilling employees and developing effective corrective actions to remediate manufacturing enforcement issues.

During his time at FDA, Chris conducted hundreds of inspections across the world. He was a District Drug Inspection Specialist and instructor at FDA’s Basic Drug Inspection School. He worked at FDA’s Beijing China Office while serving as Assistant Country Director – Drugs and worked at FDA’s New Delhi India Office as an International Policy Advisor – Drugs. His last job at FDA was a Senior Compliance Policy Advisor at CDER.

Chris began his private sector career at Hogan Lovells as a Director of Regulatory Affairs where he provided technical assistance and regulatory strategy to remediate FDA Warning Letters for two clients. Chris and Senior Associate Sally Gu developed a methodology for assessing quality management maturity for clients under FDA enforcement actions.

Chris left Hogan Lovells and joined Parexel as a VP Technical – Strategic GMP Compliance, where he served as the lead for remediating aseptic manufacturing issues. A highlight of his time at Parexel was implementing an aseptic operator behavior program for a client that received two inspection related complete response letters related to aseptic manufacturing  for a BLA. With the guidance of Chris and the rest of the Parexel team, the client passed their third Pre-Licensing Inspection and received approval for their BLA.