Lexology December 4, 2025
Reed Smith LLP

Key takeaways

  • Increased FDA Inspections and Enforcement in 2025: The FDA has ramped up its inspection and enforcement activities across industries, with more frequent inspections, longer durations, and larger inspection teams.
  • AI-Driven Targeting for Inspections: The FDA’s new AI system, Elsa, has revolutionized the targeting of inspections by using data analysis to flag high-risk facilities based on patterns in compliance data, adverse event reports, and historical inspection outcomes.
  • Foreign Manufacturers Under Increased Scrutiny: The FDA has expanded its use of unannounced inspections at foreign manufacturing facilities, particularly in countries like China and India, to ensure they meet U.S. standards.
  • Prioritize Proactive and Reactive Compliance Measures: Companies should prepare for more detailed and frequent inspections and proactively work to mitigate...

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Topics: FDA, Govt Agencies
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