China NMPA Inspection - Guilin Huanowei Biotechnology Co., Ltd. - November 16, 2021

The Guangxi Zhuang Autonomous Region Drug Administration conducted unannounced inspections of 20 cosmetics manufacturers across Guangxi between July and November 2021, with most occurring in September and October. These inspections were based on the "Key Points for Cosmetic Production License Inspection" and relevant regulatory frameworks, aiming to enhance oversight of the cosmetics industry. Key violations identified across the companies revealed systemic issues in quality management and operational compliance. Common deficiencies included a widespread lack of comprehensive training plans, records, and content consistent with current laws for employees, including technical management personnel. Many firms failed to establish essential documented procedures for processes like packaging material disinfection, production operations, and intermediate product quality standards. Inadequate record-keeping extended to equipment calibration, maintenance, and batch production information. Furthermore, several manufacturers exhibited poor facility and environmental controls. Problems included improper segregation and storage of raw materials, packaging, and finished products, as well as insufficient ventilation in warehouses. Equipment-related issues such as uncalibrated thermometers and pressure gauges, and a lack of status indicators, were also noted. Some companies were found to be sharing functional areas or equipment with other daily chemical production, posing cross-contamination risks. As a result, most inspected companies were issued rectification orders, requiring them to address deficiencies within a specified timeframe. Critically, five manufacturers faced immediate production suspension due to more severe non-compliance, highlighting the administration's commitment to enforcing stringent regulatory standards for cosmetic production safety and quality.