China NMPA Inspection - Hunan Jinchang Biotechnology Co., Ltd. - June 26, 2019

Hunan Jinchang Biotechnology Co., Ltd. was subject to an unannounced regulatory inspection on June 13-14, 2019. This inspection, conducted under cosmetic hygiene and production licensing regulations, revealed several significant non-compliance issues. Main violations included incomplete original inspection records, specifically lacking details on inspection methods and equipment. Structural deficiencies were identified, such as damaged floors in the emulsification and bottle washing rooms. Additionally, stainless steel storage tanks used for semi-finished products were not labeled with disinfection expiration dates. The company also failed to retain product samples for the required duration, with records only available from December 2018 onwards. A critical issue involved a mismatch between product packaging batch numbers and the company's internal batch definitions, complicating product traceability. Furthermore, disinfection methods for inner packaging materials, utilizing ultraviolet lamps and ozone, were neither verified nor properly documented. Consequently, the Hunan Provincial Drug Administration issued a rectification order, requiring Hunan Jinchang Biotechnology Co., Ltd. to address these deficiencies within a specified period and submit a comprehensive rectification report upon completion.