FDA Announces Expanded Use of Unannounced Inspections at Foreign Manufacturing Facilities

Summary of the FDA’s May 6, 2025, Press Release: Expanded Use of Unannounced Inspections at Foreign Manufacturing Facilities

The FDA has announced strategic shifts to address inspection challenges at foreign manufacturing facilities producing foods, essential medicines, and other medical products for American consumers and patients. This initiative will begin with a focus on facilities in China and India.

Key Points:

• Workforce Reductions: Recent layoffs at the FDA have impacted inspection support staff, potentially reducing the number of routine and foreign inspections. This has led to increased workload for inspectors, causing bottlenecks in the pre-approval inspection (PAI) and approval pipeline.
• Quality Compliance: Manufacturers must maintain current Good Manufacturing Practices (cGMP) compliance to avoid financial and legal consequences, including product recalls and enforcement actions under the False Claims Act.
• Foreign Inspections: Historically, foreign inspections have been preannounced, unlike domestic inspections, raising concerns about their effectiveness. The FDA is expanding unannounced inspections and increasing fees to address these disparities and a significant inspection backlog caused by the COVID-19 pandemic.
• Strategic Responses: The FDA is evaluating its inspection policies and exploring alternative tools, such as record requests and virtual site evaluations, to enhance oversight. An executive order directs the FDA to increase user fees and inspections of foreign plants.
• Implications for Stakeholders: Companies should prepare for increased regulatory exposure, operational impacts and strategic planning to ensure compliance and supply chain integrity. This includes strengthening vendor management systems and having robust Corrective and Preventive Action (CAPA) plans.

Key Takeaways:

• Maintain Compliance: Despite reduced inspections, manufacturers must uphold cGMP compliance.
• Prepare for Inspections: Companies should strengthen vendor management and have robust CAPA plans.
• Proactive Measures: Address prior enforcement actions and maintain audit-ready documentation.
• Strategic Planning: Evaluate supply chains and bolster internal compliance in anticipation of heightened regulatory oversight.

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