China NMPA Inspection - Changsha Yishi Rongyan Biotechnology Co., Ltd. - June 20, 2019

An unannounced inspection of Changsha Yishi Rongyan Biotechnology Co., Ltd. was conducted by the Hunan Provincial Drug Administration from June 10 to June 12, 2019. The inspection, based on regulations such as the "Cosmetics Hygiene Supervision Regulations" and "Key Points for Cosmetics Production License Inspection," identified several significant deficiencies.Key violations included the absence of regular calibration for a constant temperature water bath in the physicochemical room, indicating a lapse in quality control equipment maintenance. Furthermore, the raw material warehouse exceeded its specified temperature range, recording 28.2 degrees Celsius against a required 15-26 degrees Celsius, which could compromise material integrity. Product labeling issues were also noted: the "Plant-Based Consolidation Cream" lacked a mandatory expiration date, and semi-finished product labels in the settling room were missing essential "Material Name/Code" information. Additionally, the company's retained sample for the "Plant-Based Nourishing Care Kit" was found without its sales packaging, hindering comprehensive sample retention protocols.These findings indicated a non-compliance with the "Cosmetic Production Licensing Work Specifications." As a result, the Hunan Provincial Drug Administration issued a rectification order. Changsha Yishi Rongyan Biotechnology Co., Ltd. is mandated to correct all identified issues within a specified timeframe and subsequently submit a detailed rectification report to the regulatory authority. This action emphasizes the importance of adherence to cosmetics production and quality management standards to ensure product safety and regulatory compliance.