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# Sen. Banks Presses FDA to Ramp Up Foreign Inspections
- URL: https://www.fdaweb.com/sen-banks-presses-fda-to-ramp-up-foreign-inspections/
- Published: 2025-10-17T12:00:00.000Z
- Updated: 2026-09-14T15:24:24.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5160062

Sen. **Jim Banks** (R-IN) is urging FDA to step up inspections of pharmaceutical manufacturing facilities abroad, citing persistent quality lapses and lagging oversight in countries that supply the majority of U.S. drug ingredients.

In a 10/16 letter to FDA commissioner **Marty Makary**, Banks warned that “shoddy foreign pharmaceutical plants and unscrupulous domestic producers that import from them are nothing new,” and said the public expects the agency to do more to prevent substandard medicines from entering the U.S. supply chain. According to data cited in the letter, the agency inspected only 28% of known Chinese facilities and 33% of Indian facilities in fiscal year 2024, compared with pre-pandemic levels that were much higher. Indian facilities also accounted for the highest rate of serious GMP violations — 13% of those inspected — while nearly 40% of all import alerts were issued to Chinese sites.

Banks pointed to FDA’s own *Report on the State of Pharmaceutical Quality*, which found that overall drug plant inspections have not yet recovered to pre-COVID levels. Between fiscal years 2019 and 2021, inspection activity dropped by roughly 80%, and by 2024 had rebounded to only about three-quarters of 2019 levels — even as the number of active drug manufacturers continues to rise.

“The FDA must do more to protect the U.S. drug supply,” Banks wrote. “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 Indiana senator also endorsed the agency’s new “green list” initiative — an effort to publicly identify manufacturing facilities that meet FDA’s quality standards — but cautioned that its impact will be limited unless the agency can expand its inspection capacity.

Banks asked Makary to respond by 11/7 to a series of detailed questions, including how many overseas sites supplying the U.S. market remain unlisted in FDA’s Site Catalog, what steps are being taken to improve reporting compliance, and whether the agency plans to expand use of remote regulatory assessments and its section 704(a)(4) authority to supplement in-person inspections.

He also pressed FDA to prioritize domestic manufacturing initiatives such as the proposed PreCheck program, which would accelerate review and approval of new U.S.-based production lines. “The FDA must be ready to support the surge in investment that domestic pharmaceutical companies are making,” Banks wrote.