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 OTC manufacturer in Taizhou, Zhejiang, China, identified significant deficiencies under the regulatory framework of Current Good Manufacturing Practices (cGMP). The inspection revealed nine critical observations impacting the firm's Quality, Laboratory, Materials, and Production Systems. Key issues included a severely deficient quality control unit lacking written procedures for change control, inadequate evaluation of material changes, and the absence of quality agreements with contractors for critical responsibilities like complaint handling and stability testing. The company failed to establish product expiration dates through proper accelerated or long-term stability studies and lacked written procedures for comprehensive annual product quality reviews. Laboratory controls were found to be inadequate due to the absence of original Gas Chromatography data for released products, hindering data integrity verification, and a lack of written specifications for testing procedures. Material control was also deficient, with the company failing to perform identity and complete specification testing for raw materials, instead relying solely on supplier certificates of analysis. Furthermore, production records lacked documentation for theoretical and actual yield calculations, and batch records were incomplete regarding labeling controls, including label issuance, accountability, and specimens. The company is required to promptly address these observations by implementing robust corrective and preventative actions to ensure compliance with cGMP regulations for drug products and assure product quality and safety.