GKS Researchers Publish Study on FDA's Foreign Drug Inspection Gap

New York, NY — March 2026 — Global Key Solutions Corp. (GKS) announces the open-access publication of "The Foreign Inspection Gap: FDA GMP Oversight of U.S. Drug Imports, 2014–2024" in the Journal of Pharmaceutical Innovation (Springer Nature, Vol. 21, Article 240). The paper is co-authored by George Kwiecinski and Kevin Yuan.

About the Research

The study documents a decade-long structural divergence between U.S. pharmaceutical import growth and FDA foreign inspection capacity. Between 2014 and 2019, every additional $1 billion in drug imports was associated with 23 fewer foreign inspections conducted by FDA. The COVID-19 pandemic deepened the gap, leaving an estimated 2,000 manufacturers globally uninspected as of May 2024.

Key findings include the near-universal practice of preannouncing foreign inspections — 90% of foreign inspections were preannounced in FY2023 — compared to the unannounced standard applied to domestic facilities. The paper also examines FDA workforce shortages, MRA coverage gaps, and compliance incentive structures that have allowed the gap to persist.

The research directly anticipated FDA's May 2025 expansion of unannounced foreign inspections, now codified as U.S. policy under a White House Executive Order.

Read the full paper — Open Access, CC BY 4.0.

Research Collaborations

GKS is seeking research collaborations in GMP, pharmaceutical regulatory policy, and FDA oversight for the advancement of public health and drug supply quality. Researchers, regulators, and industry professionals with relevant expertise or data are encouraged to reach out. Anonymous submissions welcome.

Submit your interest or email [email protected].

Global Key Solutions (GKS) is committed to revolutionizing quality management in drug manufacturing and automation through innovative software solutions. GKS provides cutting-edge tools to regulated industries to improve innovation at unprecedented levels of speed, safety, and security.

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