Unannounced FDA Inspections Expand Abroad: What This Means for Global Suppliers

The FDA has announced it will expand surprise inspections at foreign manufacturing sites that produce foods, medicines and medical products destined for US consumers and patients. This builds on its Foreign Unannounced Inspection Pilot program previously conducted in India and China.

Until now, overseas facilities have typically received advance notice — often weeks — while US-based manufacturers are more frequently subject to unannounced visits. By aligning global oversight practices, the agency aims to strengthen regulatory consistency and improve transparency across its more than 3,000 annual foreign inspections conducted in over 90 countries.

Under the Federal Food, Drug and Cosmetic Act (FDCA), importers must register any foreign facility that produces, stores or handles foods and submit prior notice of each incoming shipment. All imports are held to the same safety, sanitation and labeling standards as domestic products, with the FDA authorized to inspect or detain noncompliant goods.

Even with advance notice, overseas facilities were found to have serious deficiencies more than twice as often as domestic sites. This has raised concerns about whether scheduled inspections consistently reflect standard operations before products enter the US market.

In the past, the FDA made unannounced visits domestically, such as documenting sanitation violations during a surprise audit of Taylor Farms’ Colorado Springs onion processor in November 2024.

Ahead of the announcement, CBS News reported that the FDA is developing plans to reduce its direct role in routine food safety inspections by expanding reliance on state and local agencies. While not finalized, the proposal has reportedly been under consideration for years and could require congressional approval.

Officials cited the potential to reallocate FDA resources to higher-priority and foreign inspections, though some public health advocates have raised concerns about how the shift could affect foodborne illness prevention.

As part of the expanded oversight framework, the FDA will also reinforce policies that prohibit investigators from accepting lodging or transportation arrangements from the companies they inspect. This safeguard is designed to preserve inspection independence and integrity.

While already standard practice for domestic inspections, the agency will clarify this policy for global enforcement to ensure consistent application.

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Historically, certain sectors — such as seafood and spices — have seen higher rates of pathogen-related entry refusals. According to data from the US Department of Agriculture (USDA) Economic Research Service (ERS), between 2002 and 2019, seafood products accounted for 44% of pathogen violations recorded by the FDA in imported foods, while spices, flavors and salts represented 26%.

More recently, routine inspections at overseas facilities have led to Form 483 issuances, which flag “objectionable conditions” observed during an inspection that may violate the FDCA.

In February 2025, the FDA issued six observations at Piramal Pharma’s Turbhe facility during a scheduled GMP inspection, noting procedural issues unrelated to data integrity.

That same month, a pre-approval and cGMP inspection of Syngene International’s Bengaluru sites resulted in five observations, though the specific details were not publicly disclosed.

These developments occur amid internal changes within the FDA’s inspections leadership. Michael Rogers, the agency’s associate commissioner overseeing inspections and investigations, will retire on May 14, during a period of ongoing internal discussions about inspection priorities, trip durations and resource allocation.

In the same CBS report, some FDA staff raised concerns that compressing foreign inspection trips, while aimed at expanding coverage, could limit oversight depth.

Going forward, every unannounced visit, regardless of whether it identifies compliance issues, will feed into the FDA’s inspection classification system. Even inspections that result in no immediate action can generate regulatory intelligence that informs future oversight decisions.

The agency also plans to evaluate and refine the full scope of its foreign inspection program, including procedures, resource allocation and policy implementation.

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