Sen. Banks Urges FDA to Step Up Inspections of Foreign Drug PlantsTuesday, October 14, 2025

WASHINGTON, D.C,– Today, Senator Jim Banks (R-Ind.) sent a letter to Dr. Martin Makary, Commissioner of the Food and Drug Administration, urging the agency to strengthen oversight of the U.S. drug supply amid growing concerns about poor-quality foreign manufacturers—particularly in China and India. The FDA’s inspections of drug manufacturing facilities have not yet returned to pre-pandemic levels.
In part, the letter reads:
“The FDA must do more to protect the U.S. drug supply. Unfortunately, shoddy foreign pharmaceutical plants and unscrupulous domestic producers that import from them are nothing new. The public expects the FDA to protect them from impure drugs by identifying them at the source and blocking them from entering the supply chain. The FDA’s import alerts demonstrate the extent of the problem. Among all facilities that were issued import alerts, 39% were located in China and 13% were located in India, versus the 10% average for other regions. In fiscal year 2024, the FDA only inspected 28% of Chinese facilities and 33% of Indian facilities in the Site Catalog (the list of facilities known to manufacture human pharmaceuticals for the U.S.). Of the facilities that were inspected, Indian manufacturers had the highest rate of serious “Current Good Manufacturing Practice” violations, at 13%.”
Clickheretosee the full letter or see text below:
Dear Dr. Makary:
I urge the Food and Drug Administration (FDA) to accelerate the pace of pharmaceutical manufacturing facility inspections. According to the Center for Drug Evaluation and Research’s (CDER) recent Report on the State of Pharmaceutical Quality, inspections in China, India, and even the U.S. are falling behind. While the total number of inspections is increasing, it still has not recovered to pre-pandemic levels. From fiscal year 2019 to 2021, inspections plummeted by 80%, and they have only recovered to 74% of the 2019 level. Meanwhile, the number of drug manufacturers and facilities continues to grow.
The FDA must do more to protect the U.S. drug supply. Unfortunately, shoddy foreign pharmaceutical plants and unscrupulous domestic producers that import from them are nothing new. The public expects the FDA to protect them from impure drugs by identifying them at the source and blocking them from entering the supply chain. The FDA’s import alerts demonstrate the extent of the problem. Among all facilities that were issued import alerts, 39% were located in China and 13% were located in India, versus the 10% average for other regions. In fiscal year 2024, the FDA only inspected 28% of Chinese facilities and 33% of Indian facilities in the Site Catalog (the list of facilities known to manufacture human pharmaceuticals for the U.S.). Of the facilities that were inspected, Indian manufacturers had the highest rate of serious “Current Good Manufacturing Practice” violations, at 13%.
I appreciate that the FDA has prioritized inspections in China and India, nearly returning to 2019 inspection levels, but I urge you to do more to keep pace with the risk we are facing. Similarly, the FDA’s “green list” initiative, publishing facilities that have been “inspected or evaluated that appear to be in compliance with the FDA’s rigorous standards,”[4]is encouraging, but it can only be comprehensive if many more facilities are inspected. Increased vigilance and enforcement are essential to protect the public.
At the same time, I strongly support the Administration’s initiative to prioritize inspection, review, and approval of new U.S.-based pharmaceutical manufacturing facilities, including the proposed FDA PreCheck program. This program should be expanded and expedited to include all new facilities and new lines for U.S.-based manufacturing. The FDA must be ready to support the surge in investment that domestic pharmaceutical companies are making.
I respectfully ask that you provide answers to the following questions by no later than November 7, 2025:
Thank you for your leadership. I look forward to working with you to strengthen pharmaceutical manufacturing facility inspections.
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