FDA Expands Use of Unannounced Foreign Inspections A New Compliance Era for Global Manufacturers

The U.S. Food and Drug Administration (FDA) has significantly expanded its use of unannounced and short-notice inspections at foreign facilities involved in the manufacture of pharmaceuticals, biologics, medical devices and active ingredients.

This shift aligns with the agency’s intensified post-pandemic oversight strategy and reasserts its authority in ensuring the integrity of the global supply chain.

Why This Matters Now

While domestic facilities have long been subject to unannounced inspections, the same level of scrutiny is now being extended globally. For years, inspections at non-U.S. sites were typically pre-scheduled due to diplomatic protocol or logistical challenges. That approach is ending. The FDA has confirmed that foreign manufacturers can expect increasingly spontaneous visits—with limited or no advance warning. The FDA has brought about this change to ensure there is consistent regulatory oversight and certify that the same stance is employed between domestic and foreign facility (non-U.S.) inspections.

This expanded approach targets firms supplying high-risk products and critical components, particularly in regions with a history of non-compliance. The FDA anticipates that the unannounced inspections will prevent foreign facilities from concealing violations, committing fraud, and, importantly, keeping unsafe products out of the United States. According to the FDA’s 2024 inspectional performance summary, 45% of foreign inspections revealed data integrity concerns or failure to meet basic current Good Manufacturing Practice (cGMP) standards. These findings underscore the rationale for shifting toward real-time assessment of facility practices.

Additionally, the FDA is working closely with international regulatory bodies—including the European Medicines Agency (EMA), Japan’s Pharmaceutical and Medical Devices Agency (PMDA) and Australia's Therapeutic Goods and Administration (TGA)—to share inspectional findings and intelligence. This global cooperation creates a unified front in monitoring compliance and raises the standard of care expected from all manufacturing partners, regardless of their geographical location.

Who Is Impacted?

A broad range of stakeholders across the life sciences industry must be prepared, including:

• API manufacturers
• CDMOs and CMOs
• Drug product and biologic manufacturers
• Clinical research sites and trial sponsors
• Distributors and importers
• Cell, gene and tissue-based therapy developers

Facilities that fall out of compliance with Code of Federal Regulations Title 21 parts 210, 211, 600, 820 or 1271 may face immediate enforcement actions, such as Form 483s, import alerts, warning letters or supply chain disruptions. In severe cases, non-compliance can result in loss of market authorization or criminal liability for falsified records or misbranded products.

Inspection Readiness Is No Longer Optional

With regulatory agencies leveraging digital surveillance, mutual recognition agreements and shared databases, inspectional information circulates faster and wider than ever. A finding by one authority can lead to ripple effects across markets.

Companies should not assume inspections will follow a predictable pattern. In reality, the FDA is now deploying a risk-based inspection model that prioritizes:

• Facilities with limited inspection history
• Sites with known quality issues or product recalls
• Manufacturers in countries with low regulatory transparency

To remain inspection-ready every day, organizations must implement strong quality systems, real-time data traceability and rigorous training protocols for operational and quality teams. It is essential to cultivate a site culture where regulatory compliance is embedded in daily operations—not staged for scheduled audits.

Best Practices for 24/7 Readiness

To minimize vulnerability, companies should:

• Conduct periodic mock inspections that mimic FDA protocols
• Reinforce data integrity practices through routine internal audits
• Implement robust deviation management and CAPA systems
• Ensure supply chain partners meet equivalent compliance standards
• Train cross-functional teams on inspection conduct, documentation and escalation processes

It is equally important to align inspection readiness with strategic business planning. Quality and regulatory leaders must have a seat at the executive table to flag risks, allocate resources and drive continuous improvement across global networks.

A Lasting Shift, Not a Temporary Policy

The FDA’s expanded use of unannounced inspections is not a short-term tactic. It marks a long-term evolution in regulatory oversight, built on lessons learned during the COVID-19 pandemic. Global manufacturers must shift from reactive compliance to operational resilience and readiness—because the next inspection may already be on its way.