FDA Intends to Increase Unannounced Audits of Foreign Manufacturing Facilities
June 12th, 2025 // 1:52 pm @ jmpickett
FDA announced last month that it will increase the number of unannounced cGMP inspections at foreign manufacturing plans that produce essential medicines and other medical products intended for the US market. The announcement came a few days after President Trump issued an executive order telling the FDA to give regulatory relief to increase domestic production of vital medicines, and enhance the agency’s risk-based inspection practices to increases routine FDA inspections of foreign companies.
The increased FDA audits will build upon the agency’s current Foreign Unannounced Inspection Pilot Program in China and India. The aim is to ensure that international facilities get the same degree of FDA regulatory oversight and scrutiny that US-based facilities receive. As readers probably know, domestic drug and device production sites do not usually get prior notice for routine audits. On the other hand, foreign FDA inspections are usually announced in advance. This is done in part to allow the sites to work with agency investigators on travel options and make sure there are translators available.
FY2025 saw a decrease of FDA foreign audits in China compared to the year before, with 81 inspections. Of these, 76 were for drugs and five were for devices. Four inspections were deemed OAI, meaning the FDA report for those audits recommended corrective actions. On the other hand, the number of FDA audits in China for devices and drugs rose to 227 in FY2024 over the number for the previous three years.
The president’s May 2025 executive order means FDA must develop and implement enhancements in its risk-based inspection methods within 90 days. This process will ensure that routine audits of foreign facilities that provide medicines to the US. These improvements will be paid for by higher fees on foreign facilities.
Drug and device companies need to be sure their manufacturing facilities in China are ready for inspections because there will be more unannounced audits this fiscal year. Also, companies thinking of acquiring entities that have contracts with CROs in China or manufacturing plants should focus on checking the cGMP and GLP systems in those facilities.
