FDA Expands Unannounced Foreign Manufacturing Inspections

The U.S. Food and Drug Administration (FDA) is significantly changing its approach to global oversight, expanding unannounced and short-notice inspections at foreign drug, biologic, and device manufacturing sites. This pivotal shift aims to restore inspectional rigor post-pandemic, ensuring consistent regulatory oversight between domestic and international facilities. Historically, foreign inspections were often pre-announced, but the FDA's new policy levels the playing field, intending to prevent the concealment of violations and keep unsafe products out of the U.S.

This impacts a wide range of industries, including API manufacturers, CDMOs, and drug producers. Non-compliance can lead to severe consequences. To understand what this means for your operations and how to ensure readiness, read the full article.