FDA 483 - TAIWAN BIOTECH CO., LTD. - September 20, 2022

An FDA inspection of TAIWAN BIOTECH CO., LTD. in Taoyuan City, Taiwan, a sterile drug manufacturer, revealed significant deficiencies in their quality control unit and stability testing programs. Observations included unqualified vendors, non-contemporaneous record-keeping, inadequate CAPA management, and issues with incubator qualification and monitoring. Additionally, the firm failed to properly utilize stability testing results for determining appropriate storage conditions and expiration dates for their sterile drug products.