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

An FDA inspection of TAIWAN BIOTECH CO., LTD., a sterile drug manufacturer in Taoyuan City, Taiwan, revealed significant deficiencies in its quality control unit. The firm was cited for issues including unqualified vendors, non-contemporaneous record-keeping, an inadequate CAPA system, and poor management of incubators. Additionally, the inspection found that stability testing results were not properly used to determine storage conditions and expiration dates for its sterile drug products.