In brief

On 6 May 2025, the US Food and Drug Administration (FDA) announced that it will expand the use of unannounced inspections at foreign manufacturing facilities that produce foods, essential medicines, and other medical products intended for US consumers and patients. The announcement came one day after the White House issued an Executive Order instructing FDA to provide regulatory relief to promote domestic production of critical medicines and improve FDA’s risk-based inspection regime to enhance routine inspections of foreign facilities. The expansion will build upon FDA’s existing Foreign Unannounced Inspection Pilot Program in India and China, with the aim of ensuring that foreign facilities will receive the same level of regulatory oversight and scrutiny as domestic facilities. It is important to note that domestic sites typically do not receive prior notice from the FDA for routine inspections. In contrast, foreign inspections are often pre-announced, allowing the sites to coordinate with FDA investigators on their travel plans and ensure that translators are available on site.

FDA ensures the quality of drug and medical device products by carefully monitoring both domestic and foreign manufacturers’ compliance with its Good Laboratory Practice (GLP) and Current Good Manufacturing Practice (cGMP) regulations. Along with India, China represents one of the two countries with the most foreign drug establishments subject to FDA inspection. Post-pandemic, there has been increasing pressure for FDA to resume foreign inspections in China. Indeed, we are already observing an increasing number of FDA inspections in China, which has been followed by FDA enforcement actions, even before the recent FDA announcement. Companies with manufacturing sites or suppliers based in China should ensure that the Chinese sites are prepared for the increasingly unannounced inspections.

In more detail

When we just focus on inspections of drugs and medical devices manufacturing facilities, FY 2025 initially saw a decrease in the number of FDA’s foreign inspections in China as compared to FY 2024, with 81 inspections.¹ Of these 81 inspections, 76 (93.8%) were drug inspections and 5 (6.2%) were device inspections. Four inspections (4.9%) were classified Official Action Indicated (OAI),² meaning that the inspection reports for those inspections recommended regulatory or administrative actions.³ In comparison, the number of inspections in China for drugs and devices sharply increased to 227 in FY 2024 over the levels in the preceding three years (i.e., FY 2021-2023), ranging from 8 in FY 2022 to 61 in FY 2023.

Below is a table we put together summarizing the number of inspections in the past four years on drugs and medical devices manufacturing facilities, as well as the number of inspections classified as OAI.⁴

Given the FDA’s intention to increase unannounced inspections at foreign manufacturing facilities, it is reasonable to expect a likely rise in the number of FDA foreign inspections during the remaining months of FY 2025 and continuing into FY 2026.

Under the Executive Order, within 90 days of 5 May, the FDA is required to develop and implement improvements to the risk-based inspection regime. This will ensure routine reviews of foreign manufacturing facilities that supply medicines to the United States. Notably, these improvements will be funded by increased fees on foreign manufacturing facilities, as permitted by applicable law. Additionally, the FDA will publicly disclose the annual number of inspections conducted on these foreign facilities, providing specific details by country and manufacturer.

Key takeaways

• Firms will need to ensure that their manufacturing sites in China or Chinese suppliers are inspection ready for the increasing and unannounced FDA inspections and that personnel are appropriately trained.
• Firms should proactively evaluate readiness for such FDA inspections by performing internal audits and focusing on previous findings by FDA and the GLP and cGMP implications – which might lead to FDA enforcement actions such as Import Alerts, Warning Letters, and Application Hold-up or Denials.
• Firms contemplating acquisition of entities that contract with Chinese CROs or manufacturing facilities will need to place particular focus on evaluating the GLP and cGMP processes of such facilities.
• Firms should also be prepared for increased fees on their foreign manufacturing sites.

1 Based on data gathered on FDA’s Inspections Data Dashboard, https://datadashboard.fda.gov/ora/cd/inspections.htm.
2 Id.
3 Inspections Database Frequently Asked Questions, FDA, 11 May 2020, https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/inspections-database-frequently-asked-questions – classification.
4 Based on data gathered on FDA’s Inspections Data Dashboard, https://datadashboard.fda.gov/ora/cd/inspections.htm.