Analysis of FDA Drug GMP Warning Letters for FY2022

By Barbara Unger

The data presented in this report address fiscal year (FY) 2022 and trends since FY 2013. Areas examined in the report are:

  • The time interval between inspections and warning letter issuance
  • Particular target activities that were the subject of warning letters in the past two years
  • FY2022 Warning Letter volume skewed towards the United States vs. ROW