The FDA audits, particularly the unannounced or surprise inspections, are critical to ensure the integrity of the global drug supply chains. Unannounced FDA inspections at foreign facilities pose unique logistical, legal, and cultural challenges, leading to most foreign audits being announced weeks before they occur. This week, the FDA announced that it will expand unannounced inspections at foreign manufacturing facilities, but how will be able to implement them practically?
Unannounced inspections are designed to expose noncompliance in real-time, compared to the announced visits that give the audited party time to alter, hide, and “manage” records in other ways for the inspection. The surprise audits help detect fraud, uncover lapses in safety protocols, and ensure ongoing compliance with U.S. regulatory standards. Unannounced inspections are especially valuable in identifying issues that may be deliberately concealed in advance of a known audit. In the past, some facilities have been found to falsify records, manipulate data, or temporarily “clean up” their operations when an inspection was expected. By appearing without notice, FDA investigators can observe actual day-to-day practices and determine whether the facility operates at a consistent level of quality.
However, conducting unannounced inspections abroad—particularly in India and China, which collectively supply a large portion of active pharmaceutical ingredients (APIs) and finished generic drugs to the U.S.—presents significant logistical and diplomatic challenges. In the United States, FDA inspectors can typically arrive at a domestic plant without legal barriers. But in foreign countries, the FDA must work within the constraints of national sovereignty, visa requirements, local law enforcement coordination, and diplomatic protocols.
In India, FDA inspectors have historically conducted numerous inspections, but not all have been unannounced. Language barriers, legal restrictions, and advance notice policies by host governments sometimes limit the agency’s ability to surprise facilities. In China, the situation is even more constrained. The FDA must often obtain a business visa and schedule inspections in advance, giving facilities time to prepare. During the COVID-19 pandemic, inspections in China were effectively halted for extended periods, further highlighting the risk of overreliance on foreign suppliers when regulatory access is limited.
Despite these hurdles, the FDA has developed creative approaches to maintain the integrity of its overseas inspections. One solution is the use of risk-based inspection models that prioritize facilities based on their compliance history, the volume and criticality of their exports to the U.S., and data gathered from import screenings. The FDA also partners with foreign regulators through initiatives like the Mutual Recognition Agreement (MRA) in Europe or memorandums of understanding (MOUs) with India’s Central Drugs Standard Control Organization (CDSCO), which allow for information sharing and joint inspections.
The FDA has also increased the use of remote inspections and advanced analytics. While not a replacement for on-site visits, remote inspections using secure video feeds, document reviews, and sampling plans help bridge gaps when travel is restricted. Additionally, the agency continues to advocate for enhanced legal authority and cooperation agreements to conduct unannounced inspections more effectively.
In a globalized pharmaceutical supply chain, unannounced inspections remain one of the most powerful tools to protect American patients. Ensuring that manufacturers meet high standards, regardless of where they are located, is critical for maintaining trust in the safety and effectiveness of the U.S. drug supply. Time will tell how the FDA effectively implements this expansion of unannounced inspections at foreign manufacturing sites.
