Enlightenment of FDA Warning Letter to Chinese Drug Manufacturers

Through searching the warning letter database of the US Food and Drug Administration (FDA) official website from January 2019 to December 2023, this paper sorts out and analyzes the geographical distribution and trend, and the statistics of warning letter defects issued to Chinese enterprises, putting forward some thoughts and suggestions, in the hope of providing corresponding experience and enlightenment for China's drug manufacturers to pass FDA inspection, grasping the inspection trend, paying attention to the inspection focus, and laying a good foundation for China's drugs to enter the international market.