Asian Journal Of Social Pharmacy

Objective To explore the trends in the distribution of countries to which FDA warning letters for Finished Pharmaceuticals have been issued over the past 10 years, and whether there are changes in the number of GMP violations, and to study their possible causes. Methods Public data on FDA warning letters and inspections were retrieved and analyzed using statistical methods for different classifications. Results and Conclusion Asia was the continent that received the most GMP warning letters in the last 10 years. More inspections were conducted in developed countries than that in developing countries, but they received a small number of warning letters. Quality control unit responsibilities were the most variable within all violation codes. The number of warning letters issued

by Center for Drug Evaluation and Research (CDER) for Finished Pharmaceuticals increases with the number of inspections, and the enforcement of GMP by domestic drug manufacturers is better than that of overseas drug manufacturers. In addition, drug manufacturers in developed countries are better at GMP implementation than developing countries. GMP compliance in China has become better in recent years, but it still receives more inspections and warning letters. FDA inspections of Finished Pharmaceuticals become more stringent in the last 10 years, and many quality unit issues are affected by both personnel qualifications and personnel numbers.

inspection, FDA, warning letter