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

This FDA Form 483 document outlines observations from an inspection of a facility producing active pharmaceutical ingredients (APIs). The facility's water system, used for equipment cleaning and production of most on-site APIs, was found to have issues. The 2021 Report of Water System did not address or propose corrections for consistently higher Total Aerobic Microbial Count results after the micron filter compared to feed water. Specifically, samples after the micron filter had average values above CFU/mL, and the subsequent point averaged "too numerous to count," indicating significant microbial contamination.

Furthermore, the inspection revealed deficiencies in data review and material management. There was no requirement to review electronic raw data in the chromatography system for any API batches released to date, raising concerns about data integrity and product quality assurance. Additionally, the retest date for a key starting material for an API was extended without conducting further testing, which could compromise the quality and stability of the starting material and, consequently, the final API. These observations highlight potential issues with quality control, data management, and material handling practices at the facility.