The FDA hit drugmakers in China, South Korea, India and Germany for numerous GMP and other violations observed during agency inspections. Source: Drug GMP Report

The FDA issued warning letters to drug manufacturing facilities in China and Germany for lax testing, recordkeeping and other failures. Source: Drug GMP Report

A blockchain-based drug tracking network is capable of meeting future supply chain regulatory requirements, according to pharma companies that took part in a pilot program run by the FDA. Source:…

Former FDA Commissioner Scott Gottlieb warned of the potential for “unprecedented supply chain disruptions” as the COVID-19 outbreak threatens China’s production of starting materials. The agency reported the first coronavirus-related…

The FDA flagged facilities in the U.S., China and India for deficiencies uncovered during agency inspections. Source: Drug GMP Report

The FDA sent recent warning letters to drug facilities the U.S., Canada, Australia, China and the Caribbean for serious GMP failures. Source: Drug GMP Report

Post-inspection Official Action Indicated (OAI) classifications by CDER and CBER have dropped sharply in recent years, according to the latest data from the FDA’s Inspection Classification Database. Source: Drug GMP…

The World Health Organization (WHO) and international regulators including the FDA have launched a pilot program for joint GMP inspections of sterile drug manufacturers. Source: Drug GMP Report

A federal judge has ruled that the FDA can no longer regulate barium sulfate as a drug. Source: Drug GMP Report

Switzerland’s drug agency Swissmedic rapped an Indian drugmaker for significant CGMP violations at a facility near Mumbai. Source: Drug GMP Report