FDA 483 - PharmaEssentia Corporation, Taichung Plant

An FDA inspection of PharmaEssentia Corporation, Taichung Plant, a drug substance manufacturer, revealed two significant observations. The firm failed to adequately investigate complaints of lack of therapeutic efficacy, neglecting to review manufacturing records, analytical data, or retention samples. Additionally, the bacterial endotoxin testing method was found to be inadequate due to issues with sample container validation and the use of uncalibrated equipment.