FDA 483 - Taizhou Jingshang Cosmetic Technology Co., Ltd. - November 21, 2024

An FDA inspection conducted from November 18-21, 2024, at Taizhou Jingshang Cosmetic Technology Co., Ltd., an Over-The-Counter (OTC) drug manufacturer in Taizhou, Zhejiang, China, identified significant deviations from Current Good Manufacturing Practice (cGMP) regulations. The inspection revealed critical systemic failures across multiple areas.

Key violations include an inadequate quality control unit, specifically regarding incomplete and unfollowed change control procedures for production and insufficient evaluation of material changes. The company failed to conduct proper accelerated and long-term stability studies to support drug product expiration dates, relying on limited short-term testing. Annual product quality reviews were deficient, lacking comprehensive metrics and written procedures.

In the laboratory, original Gas Chromatography data for product release was missing, hindering data integrity verification. Raw materials were not adequately tested for identity, purity, strength, and quality, with the firm relying solely on supplier certificates for critical components. Production records lacked theoretical yield calculations and complete labeling control information. The company is required to implement comprehensive corrective actions to address these observations and ensure compliance with regulatory standards for drug manufacturing.