FDA foreign inspections increase, targeting drug manufacturers without notice, as Commissioner Makary outlines new strategy.
• FDA to increase foreign drug site inspections soon.
• Inspections will occur without advance notice globally.
• Aims to enhance oversight and ensure compliance.
The U.S. Food and Drug Administration (FDA) plans to increase the number of surprise inspections at foreign drug manufacturing sites. This initiative, announced by FDA Commissioner Marty Makary, aims to enhance regulatory oversight and ensure compliance with U.S. standards. The move has been in development for several years and aligns with the agency’s broader strategy to improve drug safety and quality. Read more.
Why it matters
Increasing the frequency of unannounced inspections is crucial for maintaining the integrity of the global pharmaceutical supply chain. By conducting these inspections without prior notice, the FDA aims to identify and address potential compliance issues more effectively. This approach is expected to deter non-compliance and encourage manufacturers to adhere strictly to regulatory standards. Consequently, it could lead to improved drug safety for consumers worldwide.
What’s next
The FDA will begin implementing this strategy in the coming months, focusing on high-risk manufacturing sites across various countries. The agency will prioritize facilities that have previously shown compliance issues or are critical to the U.S. drug supply. As the FDA rolls out this initiative, it will monitor its impact on compliance rates and make adjustments as necessary. For further insights into regulatory changes, visit our Regulatory & Approvals section.