FDA 483 - Cheng Fong Chemical Co., Ltd. Dayuan Factory - August 02, 2024

Cheng Fong Chemical Co., Ltd., a drug manufacturer in Taoyuan City, Taiwan, was inspected and cited for significant deficiencies across its quality systems. The inspection revealed inadequate batch production records, ineffective deviation investigations and corrective actions, insufficient cleaning and maintenance procedures, unverified equipment operational parameters, and improper handling of incoming raw materials and storage conditions. These issues indicate a lack of control over critical manufacturing processes and quality assurance.