Enhancing Readiness For FDA's Expanded Foreign Inspection Program

By Sheila Gwizdak

Learn about the FDA’s expanded, unannounced inspection program for foreign manufacturing sites, driven by a U.S. Presidential Executive Order. This program aims to align oversight of global pharmaceutical and medical device production with domestic GMP standards. This shift places renewed focus on product quality, supply chain integrity, and regulatory accountability. U.S. sponsors using foreign manufacturers should proactively map their global manufacturing footprint, strengthen inspection readiness with robust quality systems and data integrity practices, conduct mock audits to identify compliance gaps, and foster a culture of quality throughout the supply chain. These steps will help ensure sustained compliance amid heightened global regulatory scrutiny.