June 10, 2025
In early May, the U.S. Food and Drug Administration (FDA) outlined its plans 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’s Office of Inspection and Investigations currently operates a Foreign Unannounced Inspection Pilot program in India and China that serves as the blueprint for the expansion of unannounced foreign inspections.
Aligning inspections of domestic and foreign manufacturing facilities
A key goal of the recent policy change is to ensure that foreign companies receive the same level of regulatory oversight as domestic companies. Previously, foreign manufacturing facilities were given advance notice of inspections to allow them to coordinate travel with FDA inspectors and arrange for onsite translators. In contrast, domestic manufacturing facilities only receive prior notice of inspections in specific programs and cases.
The FDA notes that announcing inspections in advance gives foreign firms sometimes weeks to prepare, “undermining the integrity of the oversight process.” Even with more time to prepare and address any potential safety violations, the FDA “still found serious deficiencies more than twice as often as during domestic inspections.”
Lawyers with Hogan Lovells caution that this announcement raises many unanswered questions, including whether the FDA will continue its longstanding practice of coordinating foreign inspections with foreign authorities. Historically, the FDA has sent an advance notification to the Competent Authority responsible for food safety in the target country, shared the inspection itinerary, and invited the Competent Authority to observe the inspections. The FDA did not address whether these practices will continue with the shift to unannounced inspections.
Enhancing food safety in foreign manufacturing facilities
In its announcement, the FDA stated that regulated companies in the U.S. do not have the authority to negotiate the date or time of an inspection, and that foreign companies should not have this power. Any firm that seeks to delay, deny, or limit an inspection, or refuses entry for an unannounced drug or device inspection may face regulatory action by the FDA.
The legal experts highlighted existing FDA guidance that outlines the consequences for foreign manufacturers who refuse an FDA inspection. These include prohibiting the sale of foods produced at foreign manufacturing facilities that have refused an FDA inspection. Other potential regulatory actions are placing the facility on Import Alert, increasing the sampling or examination of products from the facility, or other regulatory, judicial, and administrative measures.
The FDA also intends to evaluate its policies and practices for improvements to the foreign inspection program “to ensure that the FDA is the gold standard for regulatory oversight.” This includes avoiding any conflicts of interest by barring FDA investigators from accepting lodging, transportation, or other travel arrangements from regulated companies.
Looking ahead
This move to align foreign manufacturing facility inspections with domestic facility inspections is a part of the broader focus within the FDA and the Department of Health and Human Services (HHS) to strengthen global supply chain integrity and ensure that all products in the U.S. meet consistent safety and quality standards.
U.S. companies who operate foreign manufacturing facilities should ensure they are always ready for inspections and have prepared their teams to handle an unannounced inspection. They should also ensure that all overseas suppliers are aware of and comply with the new processes to prevent delays in the supply chain.
There may be an increased risk of accidental noncompliance given potential language barriers and a lack of preparation, which can result in significant enforcement activity. Companies should immediately develop and implement a plan for an unannounced inspection, which should include regular mock inspections—as well as mock recalls.
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