Be ready for unannounced foreign inspections by US FDA

This blog is part of The Regulatory Navigator series, where we explore the evolving regulatory landscape with actionable insight from Parexel's experts, sharing their experience to maximize success for clinical development and patient access.

Unannounced inspections at foreign manufacturing facilities are set to increase significantly, as announced by the US FDA in May 2025. This policy shift will have far-reaching implications for the approximately 3,000 foreign inspections that the FDA conducts annually across more than 90 countries. With initial reports of these inspections now emerging, it’s an opportune moment to consider the impact on the global pharmaceutical manufacturing landscape.¹  

It has been standard practice that foreign manufacturers were given advance notice of facility inspections, with US sites not receiving the same warning. However, this initiative aims to establish regulatory inspection parity between domestic and international producers of foods, essential medicines, and medical products destined for American consumers.¹  

This policy shift builds upon the agency's successful Unannounced Inspection Pilot Program in India and China and represents a significant step in the FDA's broader strategy to strengthen its foreign inspection program. FDA, through this initiative, seeks to improve regulatory oversight, expose potential noncompliance, and ultimately ensure the safety and integrity of products entering the US market. This announcement also aligns with other new US government initiatives that promote domestic manufacturing, such as the recent executive order (EO) for critical medicines.² 

Operational considerations for the new inspection approach  

While the objective of creating equal standards for domestic and international producers is clear, some practicalities and implications of this shift remain to be determined. These include: 

Coordination with foreign authorities: Historically, the Agency has sent advance notifications to the Competent Authority in the country where an inspection was to take place, sharing inspection itineraries and welcoming local authorities to observe. The continuation of these cooperative practices remains unclear, potentially straining international regulatory relationships. 

Resources and staffing: As of June 2024, the Agency had 51 drug investigator vacancies.³ This shortfall is attributed to various factors, including extensive travel requirements, lower starting salaries compared to industry roles, and increased competition from the private sector. Recent reductions in force at the FDA have further impacted inspection capacity. 

Inspection types and MRA  

For manufacturers in countries with a Mutual Recognition Agreement (MRA) in place (EU and UK), most inspections conducted by the FDA will be associated with applications for new products. The Pre-Approval Inspection (PAI) in response to a New Drug Application (NDA), or Pre-License Inspection (PLI) in response to a Biologics License Application (BLA), will be expected by the manufacturer, with a reasonably high level of confidence as to when it will occur in the approval process timeline. The majority of planned routine Surveillance Inspections will fall under the MRA and are unlikely to be conducted, unless risk assessment factors determine that a For-cause Inspection is warranted. 

For wider global manufacturers expecting a PAI or PLI, timings of the inspection can similarly be predicted based on the application date and review timelines.  

The main difference for these manufacturers will be in relation to the routine Surveillance Inspections, and possible For-cause Inspections they receive, in that they will now be unannounced and unexpected.⁴ 

What do you need to prepare for 

For foreign manufacturers, the possibility of an unannounced FDA inspection at any time necessitates a state of perpetual readiness, which can be challenging but is essential to avoid potential regulatory actions that could result in operational disruption and reputational damage.  

Companies that source products, or ingredients, from foreign facilities should reassess their supplier management processes. Ensuring that all partners in the supply chain understand this new FDA initiative and are prepared for unannounced inspections will be crucial in mitigating regulatory risks.  

The shift towards unannounced inspections requires a fundamental change in how facilities prepare for and manage regulatory visits. To adapt to this new reality, companies should consider the following operational changes to maintain a state of inspection readiness: 

• Conducting regular mock inspections: Simulating unannounced FDA inspections can help identify weaknesses in processes and prepare staff for the real thing. 
• Developing a clear response plan: Create and communicate a comprehensive plan for managing unannounced FDA inspections. This should include designating key personnel, establishing communication protocols, and outlining procedures for hosting inspectors. 
• Reviewing and updating documentation: Ensure all records, from batch records to standard operating procedures, are up-to-date and readily accessible. 
• Enhancing training protocols: Staff at all levels should be prepared to interact with FDA inspectors at any time. This includes understanding their roles, rights, and responsibilities during an inspection. 
• Implementing robust change control processes: With increased scrutiny, it's crucial to have well-documented and justified changes to manufacturing processes or facilities. 

The new inspection regime calls for a strategic reassessment of global supply chains and internal compliance measures. Companies should then consider: 

• Diversifying supply chains: Over-reliance on a single foreign manufacturer could pose significant risks if that facility faces regulatory action. 
• Strengthening internal compliance: Invest in quality management systems and personnel to ensure consistent compliance across all operations. 
• Enhancing transparency: Improve communication and oversight of foreign manufacturing partners to ensure they meet the heightened regulatory expectations. 
• Investing in technology: Consider implementing digital quality management systems that can provide real-time monitoring and documentation of manufacturing processes. 

Conclusions 

As the industry adapts to this new era of regulatory oversight, proactive preparation will be key. Companies that embrace these changes and invest in robust quality systems and processes will be better positioned to navigate the challenges ahead. While the transition may be demanding, it ultimately serves to enhance product quality and safety for consumers worldwide. 

By staying informed, prepared, and adaptable, stakeholders can turn this regulatory shift into an opportunity to distinguish themselves in the market through superior quality and compliance. As we move forward, the ability to maintain consistent quality under unexpected scrutiny will become a valuable competitive advantage in the global pharmaceutical and healthcare industries. 

Our team of former US, European, and China regulators offers unparalleled insights to help you navigate complex regulatory landscapes and avoid costly delays. We provide a comprehensive assessment process, including gap analysis and compliance evaluation, across your entire product pipeline, approved products, manufacturing facilities and strategies. With expertise in aseptic, biotech, and non-sterile manufacturing, coupled with remediation assistance and employee training, we ensure strong compliance outcomes aligned with industry’s best practices. 

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References 

1. FDA Announces Expanded Use of Unannounced Inspections at Foreign Manufacturing Facilities, May 6, 2025  
2. Regulatory relief to promote domestic production of critical medicines, May 5, 2025 
3. Types of FDA Inspections | FDA 
4. Drug Safety: FDA Should Implement Strategies to Retain Its Inspection Workforce | U.S. GAO 

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