China NMPA Inspection - Dalian Heyuan Daily Chemical Products Co., Ltd. - October 10, 2017

An unannounced inspection of Dalian Heyuan Daily Chemical Products Co., Ltd. was conducted on September 14, 2017, by the National Food and Drug Administration and Liaoning Provincial Food and Drug Administration. The inspection, guided by the "Key Points for Cosmetics Production License Inspection," revealed multiple deficiencies. Significant issues included an incomplete quality manager file and the quality manager's lack of required educational qualifications. Laboratory management problems encompassed the absence of a sample transfer window in the microbiology lab, incomplete original inspection records for semi-finished and finished products (lacking critical details like methods, criteria, and equipment models), and a refrigerator used for cold resistance testing without temperature control. Additionally, no agreements were in place for commissioned testing items. Equipment-related violations involved missing status labels for some production equipment, an uncalibrated pressure gauge in an emulsification pot, and absent labels for water quality monitoring sampling points on water treatment equipment. Material and product management was deficient, with no records of supplier selection or evaluation and a lack of original invoices for raw material purchases. Production management also exhibited issues with unstandardized batch production instructions. Consequently, the Liaoning Provincial Food and Drug Administration is mandated to order the company to rectify these issues within a defined period and subsequently report the rectification status to the Drug and Chemical Supervision Department of the State Administration for Market Regulation.