The U.S. Food and Drug Administration (FDA) will resume a pilot program that will lead to unannounced onsite inspections in India and China. FDA intends to start the inspections in early 2022.

Elizabeth Miller, in FDA’s Office of Regulatory Affairs (ORA), announced the forthcoming inspections during a virtual conference hosted by the Food and Drug Law Institute on December 9, 2021.

Read on to learn about FDA’s inspection pilot program and other inspection plans.

FDA’s Inspection Pilot Program

On July 13, 2020, the House Appropriations Committee released a report that, among other things, addressed the growth of oversees drug manufacturing facilities, stating that FDA’s inspections practices have not kept pace with global industry growth. The report also noted the disparity between U.S. and non-U.S. inspections.

The Committee referenced FDA’s 2014 pilot program in India, which implemented unannounced inspections. The report directed FDA to restart the pilot, which it had discontinued in 2015. The Committee also directed FDA to create an additional pilot in China.

Other Inspection News

Along with the pilot programs in India and China, FDA has adjusted inspections procedures to address an inspection backlog. FDA fell behind on inspections due to delays occurring during the COVID-19 pandemic.

Though travel restrictions have delayed certain oversees prioritized inspections, FDA plans to resume these inspections starting February 2022. Prioritized inspections, typically announced, are for products used to treat serious diseases or condition or for products related to a serious adverse event or foodborne illness outbreak.

FDA also plans to continue using a hybrid approach to conducting inspections. During the pandemic, FDA requested facilities send reports prior to onsite inspections. Miller informed the conference that this hybrid model will likely become commonplace.