FDA 483 - Chunghwa Chemical Synthesis & Biotech Co., Ltd - November 14, 2022

An FDA inspection of Chunghwa Chemical Synthesis & Biotech Co., Ltd. in New Taipei City, Taiwan, an API manufacturer, revealed significant deficiencies. Observations included inadequate monitoring of the water system's microbial counts, a lack of review for electronic raw data in the chromatography system, and improper extension of retest dates for starting materials without additional testing. These findings indicate a need for improved quality control and data integrity practices.