US lawmakers probe USFDAs inspection in India and China where they found many variations in inspection outcomes. In a new letter to Food and Drug Administration (FDA) Commissioner Robert Califf, House Energy and Commerce Committee Chair Cathy McMorris Rodgers, Subcommittee on Health Chair Brett Guthrie, and Subcommittee on Oversight and Investigations Chair Morgan Griffith are pressing for more information regarding the agency’s foreign drug inspection program.
Members discuss the Committee’s analysis of FDA inspection outcomes in India and China from January 2014 to April 2024, limiting its review to inspectors with ten or more inspections in either China or India.
The results of this analysis were surprising, revealing tremendous variation in inspection outcomes. Some FDA inspectors found compliance issues during all or almost all of their inspections. Other inspectors rarely reported finding a single compliance issue. Two inspectors never found a single compliance issue over the course of a combined 24 inspections in India.
Another inspector found zero compliance issues in 20 out of 23 inspections (85 percent) in China while finding compliance issues with almost half of domestic inspections during the same period. These are unusual inspection outcomes, the opposite of what would be expected given the widely reported failures in quality control and lack of adherence to current good manufacturing techniques by drug manufacturing facilities in China and India.
By contrast, 16 FDA inspectors, with over 325 inspections collectively in India, found compliance issues during every inspection they conducted. As a measure of what a pattern of rigorous inspections should look like, the Committee reviewed the inspection outcomes for 3 FDA inspectors with professional reputations for thoroughness who also had at least 10 inspections in China or India during the studied time period. These expert inspectors reported finding no compliance issues during inspections in China at a rate of only 6.7 to 11.4 percent and at a rate of zero to 9.5 percent in India.
The committee also sought to detail the FDA’s understanding for why the rates of Warning Letters and OAI classification for facilities in Asia Pacific China and India have dropped since the COVID- 19 pandemic. As part of the agency’s response, please identify the number of inspections where the initial findings of an inspector were downgraded by FDA personnel who were not present for the inspection.
