Controlling Contaminants: Risks to Your Supply Chain and Beyond

In the most recent edition of the Sedgwick Recall Index, Sidley lawyers Scott Kaplan and Kelly Cho, along with senior regulatory compliance director  Jay Jariwala, authored a comprehensive report focusing on the challenges posed by contaminants in the pharmaceutical industry. The report covers three case studies on benzene, nitrosamine, and diethylene glycol/ethylene glycol highlighting supply-chain vulnerabilities and emphasizing the importance of vigilance in managing risks. It also discusses recent FDA guidance on nitrosamine impurities and provides insights into the agency’s proactive approach in addressing contamination issues.