Increase in Drug WLs Shows Structural Problem: Analysis

The 303 drug Warning Letters that FDA issued in 2025 were an increase of 59% over the 190 letters it issued in 2024, according to a Krieger Scientific analysis, and early figures for 2026 indicate the trend will continue. The life sciences consulting firm says the surge in Warning Letters is not the result of isolated mistakes, but rather the “predictable outcome of a structural problem the industry has tolerated for too long.”

Krieger founder and CEO Joseph Morwald says FDA recommended that companies retain outside compliance expertise in 87% of the 2025 Warning Letters. “That is not a coincidence,” he says. “That is a diagnosis. When validation, calibration, and quality functions are managed in silos, by phase, by vendor, by department, with no single point of accountability, organizations lose the ability to catch problems before they become violations.”