Quality

House Committee Pushes FDA on Economic Adulteration

A House committee is pressing the FDA on how it’s dealing with drug adulteration for economic reasons, citing the infamous 2008 heparin contamination scandal that killed at least 81 and infected hundreds more as a prime example. Read More

FDA’s Warning Letters Show QS Failures for Finished Drugmakers

Batches of hastily assembled drug products distributed too soon and failure to document quality systems activities were among a host of GMP issues drugmakers violated, sometimes more than a year after the FDA first expressed concerns about companies’ repeated lapses during inspections. Read More