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

During an inspection conducted from November 18-21, 2024, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Taizhou Jingshang Cosmetic Technology Co., Ltd., an OTC drug manufacturer located in Taizhou, Zhejiang, China. The inspection identified nine significant observations related to the company's adherence to established quality standards for drug manufacturing.

Key issues included deficiencies within the quality system, such as inadequate written procedures for the quality control unit, failure to complete change controls for production processes, insufficient evaluation of material changes, and a lack of formal quality agreements with third parties for functions like complaint handling and stability testing. The company also failed to conduct proper stability studies to support drug product expiration dates and lacked robust annual product quality reviews. Within the laboratory system, the FDA noted that original Gas Chromatography data for finished product testing was not maintained, compromising data integrity, and written specifications for laboratory controls were incomplete. Material testing was found deficient, with the company relying on supplier certificates of analysis without performing essential identity or purity testing on raw materials. Additionally, the production system showed shortcomings, including the absence of theoretical and actual yield calculations in batch records and incomplete labeling control documentation. To comply with regulatory requirements, Taizhou Jingshang Cosmetic Technology Co., Ltd. is required to implement comprehensive corrective and preventive actions to address these deficiencies and ensure the quality, safety, and efficacy of its OTC drug products.