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# Significantly More Unannounced Foreign Inspections
- URL: https://www.fdaweb.com/significantly-more-unannounced-foreign-inspections/
- Published: 2026-11-05T23:07:00.000Z
- Updated: 2026-11-06T02:55:01.000Z
- Author: David McFarland
- Tags: Drugs, enforcement

FDA associate commissioner for inspections and investigations **Elizabeth Miller** says unannounced drug inspections in China and India increased significantly in FY 2026 compared with FY 2025 inspection numbers. As reported by the Regulatory Affairs Professional Society’s online Regulatory Focus [newsletter](https://www.raps.org/resource/fda-foreign-unannounced-inspections-in-china-and-india-increased-in-fy-2026.html?ref=fdaweb.com), she spoke at the Association for Accessible Medicines’ GRx+Biosims conference on 10/3.

According to Miller, a major agency focus for FY 2026 was to achieve equality between domestic and foreign oversight. She reported that the proportion of unannounced inspections in India increased from 47% in FY 2025 to 87% in FY 2026\. In China, she said, the percentage of unannounced inspections rose from 19% in FY 2025 to 61% in FY 2026.

“The point is not to surprise for surprise’s sake,” Miller said. “The point is to observe ordinary operating conditions, to strengthen confidence in the evidence we collect, and to create a more level inspections posture between the domestic and foreign facilities.”

The article notes that lawmakers have been critical of FDA’s foreign inspection program for many years, claiming that giving foreign manufacturers advance notice of inspections is unfair to domestic companies that are subject to unannounced inspections.

Miller noted several challenges in FDA’s foreign inspections program, including difficulties in obtaining visas for staff, securing laboratory support, and ensuring safe security conditions in the countries where inspectors will operate.

“I recognize the concern that increasing these unannounced inspections can create practical challenges particularly at global sites where key personnel and translators may not be immediately available, but the answer can’t be to recreate these long and advance notice models that undermine the value of seeing ordinary operations,” Miller said.