The U.S. Food and Drug Administration’s plans to step up the pace of surprise inspections at foreign factories that produce food and medicine to sell in the United States will force drugmakers to take swift action to ensure compliance, McGuireWoods Washington, D.C., partner Clint Narver, Dallas partner Mindy Sauter and Raleigh partner Michael Easley wrote in a June 18, 2025, Law360 article.
The FDA already conducts some foreign inspections unannounced in India and China, but many drugmakers in the European Union may see them for the first time and will no longer be able to rely on advance notice to prepare for inspections, the attorneys wrote.
The authors outlined best practices for regulated firms, including establishing regulatory compliance, implementing an inspection readiness plan, addressing supply chain and data integrity vulnerabilities, and promoting transparency.
“The latter point is particularly critical in terms of potential judicial action against foreign firms, as companies that intentionally conceal the truth are far easier targets for enforcement action than companies that make honest mistakes,” the trio wrote. “A foreign firm should ensure that its inspection readiness plan promotes transparency, and U.S. firms should evaluate their foreign partners with this critical criterion in mind.”