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

TAIWAN BIOTECH CO., LTD. in Taoyuan City, Taiwan, was inspected and received a Form 483 with four observations. The inspection revealed significant deficiencies in environmental monitoring for aseptic processing, failure to follow the stability testing program, and inadequate record-keeping for quality standards and deviation tracking. These issues indicate a lack of robust quality control and data integrity within the sterile drug manufacturing operations.