FDA has established a new cross-agency governance body, the Inspectional Affairs Council, as part of a broader effort to modernize how the agency communicates, makes decisions, and carries out its inspection responsibilities. Alongside that structural change, FDA data shows unannounced foreign inspections have sharply increased in two of the countries the U.S. relies on most for drug supplies: India and China.
What the Inspectional Affairs Council Does
The IAC brings together leadership from across FDA, including each of the Centers, the Human Foods Program, the Office of the Chief Scientist, the Office of Global Policy and Strategy, the Office of Operations, the Office of the Chief Counsel, and the Office of Inspections and Investigations. It is co-chaired by the Deputy Commissioner for Strategic Initiatives and the Associate Commissioner for Inspections and Investigations. FDA says the structure is meant to ensure an enterprise-wide perspective and operational accountability, while standardizing inspectional decision-making and improving how resources are allocated across the agency’s inspection programs.
Unannounced Foreign Inspections Are Rising Sharply
FDA is intensifying its use of unannounced foreign inspections as a tool for assessing true manufacturing quality, building on the agency’s existing pilot program in India and China. The shift shows up clearly in FDA’s own numbers:
- India: unannounced inspections rose from 47% in FY 2025 (139 total inspections) to 87% in FY 2026 year-to-date (76 total inspections).
- China: unannounced inspections rose from 19% in FY 2025 (192 total inspections) to 61% in FY 2026 year-to-date (114 total inspections).
FDA has said the goal is to give foreign manufacturing facilities the same level of regulatory scrutiny as domestic ones, which have long been subject to unannounced routine inspections while foreign facilities were typically given weeks of advance notice to coordinate travel and interpreters for FDA investigators.
Why This Matters for Importers
Facilities that have historically had weeks to prepare for an FDA visit, arrange documentation, and coordinate personnel no longer have that buffer in India and China, and the trend suggests other countries could follow. Past experience with the pilot program in these two countries showed unannounced visits uncovered more data integrity and quality issues than announced ones, which means facilities that aren’t continuously inspection-ready are at meaningfully higher risk of adverse findings.
What Importers Should Do
- Confirm that foreign manufacturing partners in India and China maintain continuous, audit-ready documentation and quality systems rather than preparing only ahead of a scheduled visit.
- Review current good manufacturing practice (CGMP) compliance status with suppliers in these countries now, since an unannounced finding can disrupt supply with little warning.
- Ask suppliers directly whether they have a written plan for handling an unannounced FDA inspection, including designated staff and translator availability on short notice.
- Watch for FDA to extend unannounced inspections beyond the current India/China focus, since the agency has signaled interest in applying the model more broadly.
Sourcing from India or China? Get ahead of unannounced inspections.
ASK Alba™: Alba’s trade compliance team can help you assess your foreign facility inspection readiness.
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