FDA 483 - Chunghwa Chemical Synthesis & Biotech Co., Ltd - November 18, 2022

An FDA inspection conducted from November 14-18, 2022, at Chunghwa Chemical Synthesis & Biotech Co., Ltd., an API manufacturer in New Taipei City, Taiwan, revealed several significant observations documented in an FDA Form 483. The inspection identified three main issues indicating potential deviations from current Good Manufacturing Practices. Firstly, the firm's water system, used for equipment cleaning and active pharmaceutical ingredient (API) production, showed persistent microbial contamination. The Total Aerobic Microbial Count consistently exceeded feed water results in several post-filtration sampling points, yet the company's 2021 report did not adequately address or propose corrections for these findings. Secondly, the inspection found a lack of systematic review for electronic raw data generated by the chromatography system for any released API batches, which is crucial for quality control. Finally, the firm improperly extended the retest date for a key starting material without conducting additional testing to confirm its continued suitability for use for multiple batches. Chunghwa Chemical Synthesis & Biotech Co., Ltd. is expected to respond to the FDA with a plan of corrective actions to address these deficiencies.