FDA Expands Surprise Inspections At Foreign Drug And Food Facilities, Targets Double Standards In Overseas Manufacturing Oversight

The U.S. Food and Drug Administration (FDA) announced its intent to expand the use of unannounced inspections at foreign manufacturing facilities that produce foods, essential medicines, and other medical products intended for American consumers and patients.

This change builds upon the agency’s Office of Inspection and Investigations’ Foreign Unannounced Inspection Pilot program in India and China and aims to ensure that foreign companies will receive the same level of regulatory oversight and scrutiny as domestic companies. 

“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,” said FDA Commissioner Martin Makary.  

On Tuesday, the FDA said it plans to review and improve its foreign inspection program to ensure it meets the highest standards for oversight. Part of this effort includes making it clear that FDA inspectors should not accept travel-related perks like hotel stays or transportation from the companies they inspect.

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The FDA conducts about 12,000 inspections annually in the U.S. and 3,000 in other countries. While U.S. companies often get surprise inspections, foreign companies usually receive advanced notice, giving them time to prepare and potentially hide problems.

Still, foreign inspections often reveal serious issues, more than twice as often as domestic ones.

In the U.S., inspections are usually unannounced unless specific programs require advance notice to ensure staff and records are available.

Even then, companies can’t pick the date or time. The FDA says foreign companies shouldn’t have that option either.

By shifting to more surprise inspections abroad, the FDA aims to better protect American consumers by catching dishonest practices, like falsifying records or hiding violations, before they cause harm.

The agency can take action against any company that tries to delay, block, or refuse an unannounced inspection.

The update follows President Donald Trump’s signed executive order on Monday to promote prescription drug manufacturing in the U.S., streamlining the path for companies to build new production sites as potential tariffs on imported medicines loom.

The order directs the FDA to reduce the amount of time it takes to approve manufacturing plants in the U.S. by eliminating unnecessary requirements, streamlining reviews, and working with domestic drugmakers to “provide early support before facilities come online,” according to a White House fact sheet.

It also directs the agency to raise inspection fees for foreign manufacturing plants, improve the enforcement of active-ingredient source reporting by overseas producers, and consider publicly listing facilities that don’t comply.

The White House estimates that it can currently take five to ten years to build new pharmaceutical manufacturing capacity, which it calls “unacceptable from a national-security standpoint.”

Amid tariff uncertainty, many companies have disclosed a wave of investments in recent months to boost production in the U.S.

• Eli Lilly And Co (NYSE:LLY) doubled domestic medicine production.
• Thermo Fisher Scientific Inc. (NYSE:TMO) announced it would invest an additional $2 billion in the U.S. over the next four years.
• Medtech firm Becton, Dickinson, and Company (NYSE:BDX) also announced its intention to invest $2.5 billion in U.S. manufacturing capacity over the next 5 years.
• Pfizer Inc. (NYSE:PFE) did not highlight investments in new manufacturing plants; it noted that they already have significant capacity and flexibility to manufacture their products in the U.S.
• Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) seeks to nearly double its manufacturing capacity through a new agreement with FUJIFILM Diosynth Biotechnologies.
• Novartis AG (NYSE:NVS) unveiled a sweeping $23 billion investment plan to expand its manufacturing and research infrastructure in the U.S. over the next five years.
• Johnson & Johnson (NYSE:JNJ) announced its plans to invest more than $55 billion in the U.S. over the next four years.
• Roche Holdings AG (OTC:RHHBY) announced that it will invest $50 billion in the U.S. over the next five years.
• Most recently, Bristol-Myers Squibb & Co.’s (NYSE:BMY) Christopher Boerner, chair and chief executive officer, shared plans to invest $40 billion in U.S. R&D, technology, and manufacturing over the next five years in an op-ed published by Stat this week.

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