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%.”
Click here to see 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:
- What steps is the FDA taking to conduct more inspections globally, and in particular in China and India?
- Approximately, how many pharmaceutical manufacturing sites supplying the U.S. market are not listed in the CDER Site Catalog? Provide a breakdown by region (i.e., United States, China, India, Canada, Europe, Latin America, and the Rest of the World).
- How many sites in each region did not submit a Drug Amount Report for calendar year 2024?
- Among “No Application” sites listed in the CDER Catalog for fiscal year 2024, how many are producing any OTC monograph drugs, prescription drugs, homeopathic products, or other products? Provide a breakdown by region.
- Why did Drug Amount Report submissions decline from calendar year 2023 to 2024? What steps is the FDA taking to improve rates of reporting and compliance?
- How many, and what percentage, of Import Alerts, recalls, and warning letters were issued for “No Application” sites, and in which regions were they located?
- According to the report, the FDA surveyed drug samples from domestic repackaging sites and concluded that their repackaging processes did not affect product quality. Have any surveys been conducted on non-domestic repackaging sites and if so, what are they indicating? If not, does the FDA plan to initiate such surveys?
- Regarding the FDA’s Mutual Recognition Agreement with the European Union, how many inspections did the EU conduct during fiscal year 2024? How is the FDA reallocating the resources that were previously used for such European inspections?
- Is the FDA utilizing Remote Regulatory Assessments or exercising its section 704(a)(4) authority in other ways as replacements for, or supplements to Drug Quality Assurance inspections? In fiscal year 2024, how many sites in which regions were inspected through section 704(a)(4) authority, and how many Import Alerts, recalls, or warning letters resulting from inspections using these authorities?
- Do Drug Quality Assurance Inspections include Remote Regulatory Assessments, or are the two distinct?
- Why did the FDA stop including average site inspection scores by region or country in its current report? Does the FDA still collect this scoring data? If so, please provide it.
Thank you for your leadership. I look forward to working with you to strengthen pharmaceutical manufacturing facility inspections.
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