The US 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.

The FDA noted that this change builds upon the agency’s Office of Inspection and Investigations Foreign Unannounced Inspection Pilot program in India and China. The program’s goal is to ensure foreign companies receive the same level of regulatory oversight and scrutiny as domestic ones.  

Certain changes to maintain the integrity of the oversight process will be made. These include clarifying policies for FDA investigators to refuse travel accommodations from regulated industry parties, such as lodging and transportation arrangements.

Besides just ensuring that every product entering the US is safe, legitimate, and honestly made, the agency believes the unannounced inspections will also help expose bad actors, such as those who falsify records or conceal violations, before they put American lives at risk. 

“The FDA’s rigorous, science-based global inspections of manufacturing facilities ensure that the food and drug products that enter the US marketplace, and the homes of American consumers, are safe, trusted, and accessible,” said Michael Rogers, FDA Assistant Commissioner for Inspections and Investigations. “These inspections provide real-time evidence and insights that are essential for making fact-based regulatory decisions to protect public health.”

No more foreign firm advantage

The FDA conducts approximately 12,000 domestic inspections and 3,000 foreign inspections each year in more than 90 countries.

The agency notes that while US manufacturers undergo frequent, unannounced inspections, foreign firms have often had weeks to prepare, undermining the integrity of the oversight process. “Despite the advanced warning that foreign firms receive, the FDA still found serious deficiencies more than twice as often than during domestic inspections,” the FDA said.

The FDA is authorized to take regulatory action against any firm that seeks to delay, deny, or limit an inspection, or refuses to permit entry for an unannounced drug or device inspection.

India, China and risks to supply chain

Approximately 32% of generic drugs and 45% of active pharmaceutical ingredients are from these two countries, said US Representative Brett Guthrie (R-KY) in July 2023, speaking on behalf of several Republican members of the House Energy and Commerce Committee (E&C).

Violations found by FDA inspectors in those regions included carcinogens in medicines and destroying or falsifying of data, E&C said.

In 2021, the non-partisan Government Accountability Office criticized the FDA’s foreign inspection program in a report published last year, noting that the FDA faced “unique challenges,” and said the agency is “inadequate at holding foreign manufacturers accountable for repeatedly violating regulations.”

That same year, the Department of Defense employed an independent testing lab to assess the quality and safety of generic drugs given to service members and veterans amid supply chain issues and shortages of certain treatments, with the goal of sizing up risks to the military’s drug supply chain.

Although the FDA announced earlier this year that it will decrease its workforce by approximately 3,500 full-time employees, it specifically stated the cuts would not affect drug, medical device, or food reviewers, nor will it affect inspectors.