Examine This Report on sterility failure investigation fda
Test content spiked at low stages with representative organisms (such as the aerobic bacterium Staphylococcus aureus, spore forming bacterium Bacillus subtilis, anaerobic bacterium Clostridium sporogenes or the fungus Candida albicans) are applied to be certain there is absolutely no inhibitory impact through the sample which may mask contaminants,