FSMA mandates that FDA conduct at least 19,200 foreign food facility inspections each year. While the number of conducted foreign inspections dropped significantly during the COVID years (2020-2022), inspections had been gradually increasing to about 1,200 in 2023 and 1,450 in 2024, gaining slightly on the target number. But the number has again fallen severely in 2025 with fewer than 500 foreign inspections conducted between January and July – the lowest rate in more than a decade (excluding 2021 and 2022).
The decrease is not really a surprise given the number of involuntary and voluntary reductions in FDA staff, from travel coordinators to inspector trainers and other support staff. In fact, while essential positions were not targeted in the RIFs, a June 2025 report found that nearly 1 in 5 positions in the agency’s human food inspection divisions were vacated due to departures voluntarily taken at the encouragement of the Administration, and a hiring freeze that was extended multiple times disenabled the agency from filling the positions. Additionally, the investigators still onboard had to expend valuable time making their own travel arrangements (including diplomatic passports, visas, and foreign authority coordination), thereby reducing the amount of time they had to be in facilities.
In addition to those hindrances, a January 2025 GAO Report stated that FDA officials “consistently stated that inspecting 19,200 foreign facilities annually is not a realistic target given FDA’s existing workforce and resources.” In fact, the highest number that FDA has been able to complete in a single year was in FY2019, when the agency inspected 1,727 foreign facilities – about 15% of the approximately 125,000 foreign food facilities subject to FDA inspection.
Due to the needed planning, cost, and typical 1- to 4-day length of foreign inspections, FDA had previously always notified foreign facilities in advance to increase the likelihood that they will be operating at the time of the planned inspection. But in May 2025, FDA announced that it would be expanding its use of unannounced inspections at foreign manufacturing facilities following a pilot program to do so in India and China. The purpose is to end the “double standard” of foreign facilities being given advance notice while US facilities receive no warning and to further ensure that foreign companies importing food to the US receive the same level of regulatory oversight and scrutiny as domestic companies. The unannounced inspections should also help provide a more accurate picture of a facility’s operations and identify issues that might otherwise be concealed. This could potentially save time for the inspector as it would eliminate pre-inspection coordination time and help to identify problems in real time, rather than having to follow up on concealed issues that could have been immediately corrected.
Another initiative that could be helpful in increasing foreign inspections is the implementation of Remote Regulatory Assessments (RRAs) for which final guidance was issued in June 2025. First introduced as a way to counter the travel restrictions of COVID, FDA concluded the remote assessments to be a beneficial oversight tool outside the pandemic era for a range of FDA-regulated products, both domestic and foreign.
While certainly not applicable in all instances, the guidance discusses RRAs having value in assisting FDA in verifying corrective actions taken in response to inspections of previously compliant manufacturers; gaining compliance insight when it was not practicable to inspect; providing information about deficient practices, leading regulatory actions and/or inspections; and informing future inspection planning. In the food programs specifically, RRAs have assisted in determining compliance with veterinary feed directive regulations, assessing foreign manufacturing process records, adding foreign establishments to import alerts, issuing warning letters, and requesting Foreign Supplier Verification Programs (FSVP) records.
Whether unannounced inspections or RRAs will help improve the number of foreign facilities investigators are able to inspect is yet to be seen, but unless both Human Foods Program personnel and resources are significantly increased, there is little chance that FDA will be able to come any closer to the FSMA target of 19,200 foreign food facility inspections per year than they’ve been able to in the past. With more than half of the food consumed in the US imported from other countries, and many of the noncompliances found in foreign facility inspections being GMP related, increasing the number of inspections is a crucial goal; but perhaps it should be made a bit more realistic – one way or the other.
For those reading this who are importers or foreign manufacturers, an important message is that while the likelihood of an FDA inspection may be low, when it does happen, it will likely be unannounced and, thus, of potentially high impact to the business.
