Every drug, no matter how well designed, can become dangerous with poor quality control during production. Inadequate sterilization, mis-dosing, cheaping out on

Every drug, no matter how well designed, can become dangerous with poor quality control during production. Inadequate sterilization, mis-dosing, cheaping out on ingredients, wrong temperatures/times for chemical reactions, broken mixers, you name it. And verifying that a factory has adequate QC doesn't just mean walking the factory floor to check everything is correct (although that is a good start). It also means checking that the factory has a QC program: that management has implemented quality checks and acts on quality issues; that staff are able to flag issues (without retaliation and with reports that get acted on); that they demand the same from suppliers etc etc. We absolutely need the FDA going to factories, not (just) to observe the actual technicians but to inspect the overall way the factory functions wrt quality.