FDA 483 - Chunghwa Chemical Synthesis & Biotech Co., Ltd - April 12, 2024

An FDA inspection of Chunghwa Chemical Synthesis & Biotech Co., LTD., an API manufacturer, revealed significant deficiencies in their quality systems. Observations included failures in establishing written procedures for process monitoring and validation, inadequate investigation records for critical deviations and out-of-specification events, and a lack of control over quality unit responsibilities and electronic data storage.