FDA 483 - TAIWAN BIOTECH CO., LTD. - September 11, 2017

TAIWAN BIOTECH CO., LTD. in Taoyuan City, Taiwan, was inspected regarding its sterile drug manufacturing operations. The inspection revealed significant deficiencies in environmental monitoring for aseptic processing, failures in following the stability testing program, and inadequate record-keeping for quality evaluations and deviation tracking. These issues indicate a lack of robust quality control and data integrity practices.