In the beginning of May, the U.S. Food and Drug Administration (FDA) announced a significant update to its regulatory approach: the expanded use of unannounced inspections in foreign manufacturing facilities, including those producing foods, essential medicines and other medical products, including medical devices.
In the beginning of May, the U.S. Food and Drug Administration (FDA) announced a significant update to its regulatory approach: the expanded use of unannounced inspections in foreign manufacturing facilities, including those producing foods, essential medicines and other medical products, incluidng medical devices.
This initiative reflects the FDA’s commitment to improving supply chain oversight and ensuring consistent manufacturing standards worldwide. According to the agency, unannounced inspections will:
- Promote greater transparency and accountability;
- Strengthen the FDA’s ability to identify and act on compliance issues; –
- Reduce risks related to advance preparation or inspection avoidance.
The expanded approach builds on the pilot implementations in India and China, regions that represent a substantial share of foreign manufacturing for the U.S. market.
📄 The full announcement is available here.
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