China NMPA Inspection - Hunan Huashan Village Medical Technology Co., Ltd. - December 24, 2021

The Hunan Provincial Drug Administration conducted an unannounced inspection of Hunan Huashancun Medical Technology Co., Ltd., with results announced on December 23, 2021. The inspection revealed multiple significant non-compliance issues with China's "Cosmetics Supervision and Management Regulations" and "Cosmetics Production Licensing Work Specifications." Key violations included organizational deficiencies, such as the quality and production managers holding overlapping roles. In quality management, the company failed to maintain complete and traceable production and inspection records. Facility issues were identified in the microbiology laboratory, which lacked proper air purification, and inadequate separation for packaging material storage. Furthermore, the company could not provide records for air environment, water quality monitoring, or equipment cleaning. Material management failures included inadequate sample retention and improper material acceptance procedures. Critically, the company is suspected of using raw materials that violate national mandatory standards. As a result, authorities have launched an investigation, ordered a suspension of production and sales for affected products, mandated a recall, and required the company to rectify all identified deficiencies within a set timeframe. Resumption of production is contingent upon a follow-up inspection confirming full compliance.