The US Food and Drug Administration (FDA) has communicated a major expansion of its unannounced inspections at foreign manufacturing sites. These inspections will now be applied more widely to overseas facilities producing food, pharmaceuticals, and medical products intended for the US market.
In the past, foreign facilities have received advance notice of FDA inspections which differs to the process in the US where audits are usually surprises. This discrepancy has led to what the FDA now calls a double standard. The FDA conducts roughly 12,000 domestic and 3,000 foreign inspections each year across more than 90 countries. While foreign firms often have weeks to prepare, US manufacturers are rarely given advance notice—highlighting a significant regulatory gap. But even with prior notice, foreign inspections have revealed serious violations at more than twice the rate of domestic inspections.
The initiative builds on the FDA’s Foreign Unannounced Inspection Pilot Program, which has been active in India and China – two key exporters of food and pharmaceutical products to the US.
The new policy will:
- Increase the effectiveness and authenticity of inspections
- Deter non-compliance and falsification of records
- Ensure equal treatment for all suppliers, regardless of location
- Protect American consumers with real-time intelligence on manufacturing risks
Key aspects of this new policy include:
- Wider use of unannounced inspections across more foreign sites
- Zero tolerance for facilities that delay or deny entry to FDA inspectors
- A review of agency practices to eliminate industry-sponsored travel arrangements for inspectors, preserving the objectivity and independence of audits
- Enforcement actions against facilities that attempt to obstruct or limit inspections
If your supply chain includes foreign manufacturing partners, now is the time to:
- Review your suppliers’ compliance and audit readiness
- Ensure facilities can accommodate unannounced inspections at any time
- Confirm that documentation and records are consistently up to date
This will create a stronger foundation for product safety and quality—but will also require importers to validate their supply chains incorporate reputable suppliers. With more frequent, surprise inspections overseas, having a solid compliance program and trustworthy partners in place has never been more important.
The FDA has set up an FAQ page here with more info.
