FDA To Increase Surprise Inspections at Foreign Food and Drug Manufacturing Facilities

Agency seeks to improve oversight of foreign-made food and drug products, with a focus on facilities in India and China.

Federal regulators have announced a plan to increase surprise inspections at foreign manufacturing facilities, indicating they are addressing a long-standing problem with the safety of imported food and medicine entering the country.

The U.S. Food and Drug Administration (FDA) issued a press release on May 6, indicating it plans to expand its Office of Inspection and Investigations Foreign Unannounced Inspection Pilot program in India and China.

The FDA has faced criticism over a lack of foreign inspections for years. In 2021, during the COVID-19 pandemic, the Government Accountability Office (GAO) released a report that the agency had largely paused such inspections during the outbreak. The report found there were only three foreign inspections done throughout all of fiscal year 2020.

However, the GAO had been pressuring the agency to improve its foreign inspection efforts even before the pandemic. A report issued a decade earlier warned that, at the FDA’s pace at the time, it would take nine years to inspect every foreign facility, and inspection numbers have declined even further since then.

A significant portion of the American drug supply comes from foreign manufacturers. As of 2021, more than 50% of manufacturers supplying the U.S. market are located overseas, with the majority in India and China. In addition, roughly 73% of establishments manufacturing active ingredients, and 52% of those manufacturing finished drugs for the U.S. were located overseas. Other countries producing a large portion of the American drug supply include Germany, Italy, UK, France, Canada, Japan and Spain.

Those numbers are expected to drop precipitously with the new tariffs put in place earlier this year, which could significantly reduce the number of facilities that need inspecting.

“For too long, foreign companies have enjoyed a double standard—given advanced notice before facility inspections, while American manufacturers are held to rigorous standards with no such warning. That ends today,” FDA Commissioner Dr. Martin A Makary said in the press release. “This is a key step for the FDA as part of a broader strategy to get foreign inspections back on track.”

Currently, the FDA estimates it conducts 3,000 foreign inspections per year in more than 90 countries, compared to 12,000 domestic inspections. However, the agency claims that foreign facilities are given too long to prepare for inspectors, sometimes weeks.

The press release notes that, even with advanced warning, FDA inspectors find serious deficiencies at foreign facilities twice as often as they do at domestic ones.

The FDA does not indicate how it intends to increase the surprise inspections, whether through hiring more inspectors, or providing more funding to the program, or both.