Department of Health and Human Services (HHS) Criticizes FDA’s Foreign Inspection Practices

Background: The HHS OIG Audit of FDA Operations

The Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) conducted a comprehensive audit of the FDA’s foreign for-cause drug inspection program and issued a report identifying significant deficiencies in FDA’s practices. This represents an unusual but important situation where HHS, as FDA’s parent organization, conducted an independent evaluation of FDA’s performance and issued formal findings requiring corrective action.

For those unfamiliar with the U.S. regulatory structure, the Office of Inspector General operates as an independent watchdog within HHS, with the authority to audit and investigate programs across all HHS agencies, including FDA. While OIG is organizationally part of HHS, it functions independently to ensure accountability and identify areas for improvement in government operations.

Scope of the OIG Audit

The OIG review examined FDA’s foreign for-cause drug inspections during two distinct periods:

• Period 1: 64 inspections conducted from January 1, 2016, through March 31, 2017
• Period 2: 68 inspections conducted from January 1, 2018, through March 31, 2019

This timeframe was strategically selected to evaluate whether FDA’s 2017 programmatic changes—which included a structural realignment of the Office of Regulatory Affairs (ORA) from a geography-based model to a program-based model and new internal collaboration policies—had successfully improved the inspection process.

For-cause inspections, also called “for-cause” or “directed” inspections, are triggered when FDA has reason to believe a facility has serious manufacturing quality problems, or when FDA wants to evaluate whether a facility has adequately corrected previously identified violations. These inspections are distinct from routine surveillance inspections and typically involve higher regulatory stakes.

Key Findings of the Audit

The OIG audit identified several critical deficiencies in FDA’s foreign for-cause drug inspection program:

1. Non-Compliance with Established Policies and Procedures

FDA did not consistently follow its own policies and procedures for foreign for-cause inspections. Specific issues included:

• Failure to record certain required information in Establishment Inspection Reports (EIRs), such as whether an inspection was announced or unannounced
• Inconsistent adherence to timeliness requirements throughout various stages of the inspection process
• Delays in completing regulatory actions following inspections

2. Inadequate Documentation of Inspector Training

FDA could not provide documentation to support that all lead investigators had completed required training before conducting inspections. Specifically:

• Six of the 65 lead investigators reviewed in the audit lacked documentation showing they had completed the required training courses and passed the Level 1 Performance Audit necessary to obtain Level 1 Investigator Certification
• FDA did not have policies and procedures requiring supervisors to verify that lead investigators completed required training prior to being assigned to inspections
• According to FDA officials, training records were lost due to multiple office relocations

This finding is particularly noteworthy because inadequate training documentation is one of the most common observations FDA itself issues during inspections of regulated companies—creating an ironic situation where FDA was cited for the same type of deficiency it regularly identifies in industry.

3. Resource Constraints and Process Inefficiencies

FDA attributed these deficiencies to several factors:

• Limited resources for conducting foreign inspections
• Unexpected events and complex circumstances that disrupted planned activities
• Workload pressures on personnel responsible for finalizing inspection classifications, issuing warning letters, and conducting regulatory meetings

The Six Recommendations from OIG to FDA

Based on its findings, the OIG issued six formal recommendations to FDA, all of which FDA concurred with and committed to addressing:

Recommendation 1: Improve Timeliness of Foreign For-Cause Inspections FDA should identify and implement additional ways to improve the timeliness of its foreign for-cause drug inspection process. This includes reducing delays in initiating inspections, conducting on-site work, completing classifications, and taking follow-up regulatory actions.

Recommendation 2: Streamline EIR Writing and Review Process FDA should consider streamlining the process for writing and reviewing Establishment Inspection Reports (EIRs) to minimize potential delays due to unexpected events. As of March 2024, this recommendation has been marked as “Closed Implemented,” indicating FDA has successfully addressed this issue.

Recommendation 3: Conduct Workload Analysis FDA should conduct an analysis of the workloads of individuals responsible for: (1) determining final classification of inspections, (2) issuing warning letters, and (3) holding regulatory meetings. FDA should then address any potential issues identified by this analysis.

Recommendation 4: Implement Training Verification Policies FDA should implement policies and procedures to ensure that lead investigators assigned to inspections have completed the Level 1 Investigator Certification Process before being assigned to conduct inspections. As of November 2025, this recommendation has been marked as “Closed Implemented.”

Recommendation 5: Verify Qualifications When Records Don’t Exist FDA should ensure that supervisors review investigators’ qualifications and document that they meet applicable training requirements when the investigator training records do not exist. As of May 2024, this recommendation has been marked as “Closed Implemented.”

Recommendation 6: Review Training Records Outside Audit Scope FDA should review the training records of lead investigators who were outside the scope of the audit to verify that documentation supports either that: (a) the investigators completed the required training courses, Level 1 Performance Audit, and Level 1 Investigator Certification, or (b) the investigators are recommended as “experienced investigators” by supervisors and have completed training courses equivalent to the current required training courses. As of May 2024, this recommendation has been marked as “Closed Implemented.”

FDA’s Response and Implementation Progress

In its written response to the draft OIG report, FDA concurred with all recommendations and outlined specific actions it would take:

• Working to improve the timeliness of the overall foreign for-cause inspection process
• Committing to specific goals regarding the timing of foreign facility follow-up inspections (pending Congressional approval)
• Addressing ways to reduce time spent writing and reviewing EIRs
• Conducting workload analysis for individuals responsible for key inspection-related activities
• Implementing a new system to better document and track investigators’ qualifications and certification

As of January 2026, four of the six recommendations have been closed as implemented, demonstrating significant progress in addressing the identified deficiencies. Two recommendations remain open with expected completion dates in 2025.

Recent Developments: Expansion of Unannounced Foreign Inspections (2025)

Since the OIG audit, significant regulatory changes have occurred that directly address some of the underlying concerns about foreign inspection practices:

May 2025 Policy Shift

On May 6, 2025, FDA announced a major policy change: the expansion of unannounced inspections at foreign manufacturing facilities. This announcement came one day after President Trump signed an executive order on May 5, 2025, titled “Regulatory Relief to Promote Domestic Production of Critical Medicines,” which directed FDA to enhance its foreign inspection program.

Key aspects of the new policy include:

1. Elimination of the “Double Standard”: Historically, nearly 90% of FDA’s foreign inspections were pre-announced, giving foreign manufacturers weeks to prepare, while domestic U.S. manufacturers typically face unannounced inspections. The new policy aims to eliminate this disparity and hold foreign facilities to the same standards as domestic facilities.
2. Expansion Beyond India and China: The policy builds on FDA’s existing Foreign Unannounced Inspection Pilot Program, which was initially launched in India and China in 2014 (paused in 2015, restarted in 2021). The new announcement expands unannounced inspections to foreign facilities in all countries.
3. Enhanced Inspection Independence: FDA clarified policies prohibiting investigators from accepting travel accommodations (lodging, transportation) from regulated companies to maintain inspection integrity.
4. Increased User Fees: The executive order directs FDA to fund increased foreign inspections through higher user fees on foreign manufacturing facilities, to the extent permitted by law.
5. Shorter, More Efficient Inspections: FDA Commissioner Martin Makary indicated plans to reduce the duration of foreign inspection trips, stating inspectors would “get in and out” rather than “hanging out for three to four weeks,” enabling FDA to conduct more inspections with existing resources.

The Scale of the Challenge

Understanding the context helps explain the significance of these changes:

• Manufacturing Concentration Abroad: According to FDA data, approximately 74% of active pharmaceutical ingredient (API) manufacturers and 54% of finished drug product manufacturers for the U.S. market are located outside the United States.
• Inspection Volume: FDA conducts approximately 12,000 domestic inspections and 3,000 foreign inspections annually across more than 90 countries.
• Post-Pandemic Backlog: The COVID-19 pandemic led to suspension of most FDA inspections beginning in March 2020, with regular international inspections resuming only in 2022. As of May 2024, approximately 2,000 pharmaceutical manufacturing firms had not been inspected since before the pandemic, including over 340 plants in India and China. Under FDA guidelines, factories uninspected for five years or more are considered a significant risk and should be prioritized for mandatory inspection.
• Staffing Challenges: As of June 2024, FDA faced 225 vacancies in its inspection workforce—nearly four times the pre-COVID number. Contributing factors include extensive travel requirements (up to 50% of the time), lower starting salaries compared to private sector positions, and competition from industry where former inspectors can earn more than double their FDA salary.

Evidence of the Pre-Announcement Problem

The rationale for expanding unannounced inspections is supported by FDA’s own data: even with advance notice providing weeks for foreign facilities to prepare, FDA still found serious deficiencies at foreign sites more than twice as often as at domestic sites during the audit periods. This strongly suggests that pre-announced inspections were not effectively capturing the true state of operations at foreign facilities.

International Regulatory Context

It’s important to understand that FDA’s approach to foreign inspections must navigate complex international considerations:

Coordination with Foreign Governments: Historically, FDA has coordinated with host country governments before conducting foreign inspections, including:

• Sending advance notification to the relevant Competent Authority responsible for pharmaceutical or food safety
• Sharing inspection itineraries once planned
• Welcoming host country observers during inspections

Sovereignty and Access Issues: Unlike domestic inspections, FDA’s statutory inspection authority (21 U.S.C. § 374) does not automatically apply in foreign jurisdictions. FDA typically must coordinate with local health authorities and respect host country regulations regarding entry and inspection activities. This creates logistical complexities that don’t exist for domestic inspections.

Questions About Future Practice: It remains unclear whether FDA will continue these coordination practices as it expands unannounced inspections, or whether new diplomatic arrangements will be necessary to facilitate surprise inspections while respecting international protocols.

Implications for Regulated Industry

The combination of the OIG audit findings and the 2025 policy changes creates several important implications for pharmaceutical manufacturers, especially those operating foreign facilities or sourcing from foreign suppliers:

Heightened Compliance Requirements

1. Continuous Inspection Readiness: With the expansion of unannounced inspections, foreign manufacturers can no longer rely on advance notice to prepare for FDA visits. Facilities must maintain continuous compliance rather than engaging in pre-inspection remediation.
2. Documentation Systems: The OIG’s criticism of FDA’s own documentation failures highlights the critical importance of maintaining complete, accurate, and readily accessible documentation of all GMP-related activities, training records, and quality system operations.
3. Training and Qualification Programs: The audit’s finding regarding inadequate training documentation for FDA inspectors underscores the importance of robust training programs with comprehensive documentation. Companies should ensure all personnel involved in manufacturing operations have completed required training, and that documentation clearly demonstrates compliance with training requirements.

Supply Chain Considerations

• Supplier Qualification: Companies that source materials or products from foreign manufacturers must implement rigorous supplier qualification programs, including on-site audits and ongoing monitoring, as FDA’s enforcement actions against foreign facilities can directly impact supply chain reliability.
• Risk-Based Approach: As FDA implements its enhanced risk-based inspection regime, companies should conduct their own risk assessments of foreign manufacturing operations and supply chain partners, prioritizing oversight based on factors such as product criticality, facility compliance history, and complexity of operations.

Regulatory Strategy

• Import Alert Awareness: FDA’s enforcement toolkit for foreign manufacturers includes Import Alerts, which can prevent products from entering the U.S. market. The expansion of unannounced inspections may lead to increased use of Import Alerts, making it essential for companies to have contingency plans for potential supply disruptions.
• Proactive Communication: Companies should consider establishing clear protocols for responding to unannounced inspections, including designation of trained inspection teams, procedures for immediate notification of corporate quality and regulatory affairs leadership, and strategies for effective communication with inspectors.
• Mock Inspections: Regular mock FDA inspections can help prepare teams for unannounced visits and identify potential compliance gaps before FDA arrives.

The Broader Accountability Framework

The OIG audit of FDA illustrates an important principle in the U.S. regulatory system: regulatory agencies themselves are subject to oversight and accountability. This creates a check-and-balance mechanism that helps ensure regulatory agencies maintain high standards in their own operations.

Multi-Level Oversight Structure

The U.S. system includes multiple levels of oversight:

• Congressional Oversight: Congress regularly examines FDA’s performance through committee hearings, budgetary reviews, and specific mandates in legislation (such as the Foreign Unannounced Inspection Pilot Program, which was mandated by Congress in the FY2022 appropriations bill).
• Government Accountability Office (GAO): As the investigative arm of Congress, GAO conducts audits and evaluations of FDA programs and makes recommendations. GAO has issued multiple reports criticizing FDA’s foreign inspection program, including findings that FDA failed to meet statutory requirements (such as the FDA Food Safety Modernization Act’s mandate for 19,200 foreign food facility inspections annually, compared to only 1,727 actually conducted in FY 2019, representing just 9% of the requirement).
• Office of Inspector General: As demonstrated by this audit, the OIG within HHS provides independent oversight of FDA operations and has the authority to issue formal recommendations requiring agency response and corrective action.

The Value of Self-Examination

The irony of FDA being cited for inadequate training documentation—one of the most common deficiencies FDA identifies in its inspections of industry—actually demonstrates the value of robust oversight systems. When regulatory agencies are held to high standards and required to correct their own deficiencies, it:

• Builds credibility for the regulatory system as a whole
• Ensures agencies “practice what they preach”
• Promotes continuous improvement in government operations
• Demonstrates that no entity is above scrutiny or exempt from accountability

Current Status and Looking Forward

As of January 2026, the FDA inspection program is in a state of significant transition:

Implementation Progress: FDA has successfully closed four of the six OIG recommendations as implemented, demonstrating concrete progress in addressing documented deficiencies. The remaining open recommendations are scheduled for completion in 2025.

Policy Evolution: The May 2025 expansion of unannounced foreign inspections represents a fundamental shift in FDA’s approach to foreign oversight, moving toward parity between domestic and foreign inspection practices.

Practical Challenges: Significant questions remain about FDA’s capacity to implement expanded unannounced foreign inspections given staffing constraints, recent personnel changes (including the retirement of key inspection leadership), and the ongoing inspector shortage. The recent reduction-in-force at FDA, which reportedly affected thousands of staff including those responsible for inspection logistics, adds further uncertainty about implementation timelines and scope.

Executive Direction: The Trump administration’s May 2025 executive order explicitly links enhanced foreign inspections to broader goals of promoting domestic pharmaceutical manufacturing and improving U.S. supply chain resilience. Within 90 days of May 5, 2025 (by August 3, 2025), FDA is required to develop and implement improvements to its risk-based inspection regime.

Transparency Requirements: The executive order also requires FDA to publicly disclose the annual number of inspections conducted at foreign facilities, with specific details by country and manufacturer, enhancing transparency and accountability.

Key Takeaways for Industry Stakeholders

1. Foreign manufacturers and their U.S. customers should prepare for unannounced FDA inspections by ensuring continuous compliance with current Good Manufacturing Practice (cGMP) requirements rather than periodic pre-inspection remediation.
2. Documentation remains paramount: Both the OIG audit findings and FDA’s own inspection practices emphasize the critical importance of complete, accurate, and accessible documentation of all quality-related activities.
3. Training programs require rigorous documentation: Organizations must not only provide adequate training but also maintain comprehensive records demonstrating that personnel have completed required training and maintain necessary qualifications.
4. Supply chain risk management becomes more critical: Companies should enhance their oversight of foreign manufacturing partners through increased auditing, continuous monitoring, and robust supplier qualification programs.
5. The regulatory landscape continues to evolve: Organizations must stay informed about ongoing changes in FDA’s foreign inspection policies and adjust their compliance strategies accordingly.
6. Accountability works both ways: The OIG audit demonstrates that regulatory standards apply to regulatory agencies as well as regulated industry, creating a system of mutual accountability that ultimately strengthens public health protection.

Accessing the Full OIG Report

The complete OIG audit report, titled “The Food and Drug Administration’s Foreign For-Cause Drug Inspection Program Can Be Improved To Protect the Nation’s Drug Supply” (Report Number: A-01-19-01500), was issued on June 24, 2022, and is publicly available on the HHS OIG website at: https://oig.hhs.gov/reports/all/2022/the-food-and-drug-administrations-foreign-for-cause-drug-inspection-program-can-be-improved-to-protect-the-nations-drug-supply/

This article reflects regulatory information current as of January 2026. Readers should verify current requirements and guidance directly with FDA and monitor ongoing policy developments, particularly regarding implementation of the expanded unannounced inspection program and completion of the remaining open OIG recommendations.