Executive Summary

On May 6, 2025, the U.S. Food and Drug Administration (FDA) announced that it will significantly expand the use of unannounced inspections at foreign manufacturing facilities producing drugs, biologics, devices, and other regulated products for the American market. This decision represents a pivotal regulatory shift—one that moves beyond the long-standing practice of largely pre-announced foreign audits and aligns international oversight with the surprise inspection model long applied to domestic facilities.

For non-U.S. manufacturers — especially those supplying active pharmaceutical ingredients (APIs), finished dosage forms, biologics, and complex medical products — this change means inspectors can now arrive without warning or prior notification.

For facilities in India, China, Southeast Asia, Europe, and Latin America, this will require continuous readiness and cultural adaptation to meet FDA expectations without the buffer of preparation time.

Why This Policy Matters Now for Overseas Facilities

1. Increased Scrutiny for Exporters — The FDA is prioritizing sites supplying high-volume or high-risk products to the U.S. market.
2. Pilot Program Lessons — India (2022) and China (2023) pilots uncovered more data integrity and quality violations when inspections were unannounced.
3. Post-Pandemic Backlog — Surprise visits help FDA address the inspection backlog created during COVID-19 travel restrictions.
4. Leveling the Playing Field — Domestic manufacturers have long faced unannounced visits; this policy removes the ‘double standard’ for overseas facilities.
5. Data Integrity Enforcement — Overseas sites are under closer review for documentation, electronic recordkeeping, and batch release processes.

Current Trends Affecting Non-U.S. Facilities

• Risk-Based Targeting — Facilities with past compliance issues or critical product categories face more inspections.
• Data Governance Pressure — Retrospective or incomplete documentation is a top violation in overseas inspections.
• Global Regulatory Collaboration — EMA, WHO, and other regulators are increasing joint inspection programs.
• Technology-Driven Selection — AI tools analyze production, shipment, and complaint data to identify higher-risk sites.

Challenges and Strategic Reflections for Overseas Manufacturers

• FDA faces resource limitations, including staffing shortages and geopolitical barriers, such as China’s anti-espionage laws restricting access to some manufacturing sites.
• The agency’s ability to consistently conduct unannounced inspections worldwide remains uncertain despite strong regulatory intent.
• For industry, surprise inspections may cause short-term volatility, including import alerts or warning letters that can disrupt supply chains.
• Long-term, the initiative is expected to build greater trust in product quality and reduce systemic risks linked to unreliable overseas manufacturing.
• Key operational challenges include:
  • Cultural and language gaps can lead to miscommunication and escalate inspection findings.
  • Facilities accustomed to preparing only for announced inspections must shift to continuous readiness.
  • Outdated infrastructure and reliance on paper-based systems increase the risk of noncompliance during inspections.

Practical Readiness Insights from Our Experience

From a regulatory affairs perspective, companies cannot afford to treat compliance as a periodic exercise. Instead, inspection readiness must become a continuous state. Key strategies include:

1. Build Continuous Readiness Programs
   • Maintain documents, SOPs, and training logs in inspection-ready condition at all times.
   • Conduct mock unannounced audits with a third-party auditor.
   • Train staff in both compliance requirements and inspection communication skills.
2. Strengthen Data Integrity Systems
   • Enable and regularly review audit trails on all electronic systems.
   • Require contemporaneous recordkeeping — no backdating or ‘after-the-fact’ entries.
3. Prepare for Communication Challenges
   • Keep English-language versions or translations of essential SOPs.
   • Designate bilingual staff or interpreters for inspections.
4. Mitigate Supply Chain Risk
   • Map high-risk suppliers and include no-notice audit rights in contracts.
   • Develop contingency sourcing plans for critical materials.
5. Regulatory Intelligence Monitoring
   • Tracking FDA inspection metrics, including Form 483 trends at foreign sites, provides an early warning system for risk management

Conclusion

The FDA’s expanded surprise inspection program raises the compliance bar for foreign facilities. Those who adapt by embedding inspection readiness into daily operations will protect their U.S. market access and strengthen regulator relationships.

The Wockhardt case reminds us what is at stake: without robust oversight, the integrity of global supply chains—and the safety of patients—can be compromised.

As the industry adapts, regulatory leaders must invest in readiness systems, train personnel for new inspection dynamics, and prepare contingency strategies for supply-chain disruptions. Ultimately, companies that internalize continuous quality culture will not only withstand the scrutiny of unannounced inspections but also gain a competitive edge in an environment where trust and reliability are paramount.

References

1. S. Food and Drug Administration. FDA Announces Expanded Use of Unannounced Inspections at Foreign Manufacturing Facilities. May 6, 2025.
2. 8 Ways Overseas Drug Manufacturers Dupe the FDA. 2019.
3. White & Case LLP. FDA Foreign Inspections: Key Developments and Strategic Shifts. 2025.
4. Cooley LLP. FDA Expands Unannounced Inspections at Foreign Manufacturing Facilities. May 13, 2025.
5. FDA Expands Unannounced Foreign Manufacturing Inspections. 2025.
6. Financial Times. China’s anti-espionage law raises barriers to FDA inspections. 2023.