China NMPA Inspection - Harbin Michelle Cosmetics Co., Ltd. - June 12, 2017

Harbin Michelle Cosmetics Co., Ltd. (also known as Harbin Mixueer Cosmetics Co., Ltd.) underwent a supervisory inspection by the State Food and Drug Administration and the Heilongjiang Provincial Food and Drug Administration from March 30-31, 2017. The inspection revealed significant deficiencies within the company's quality management system, leading to a mandate for immediate rectification. Key issues identified included inadequate production workshop facilities, which lacked essential dedicated rooms for container washing, sanitary ware washing, and laundry. Laboratory management also exhibited critical shortcomings, such as the absence of a biochemical incubator and a microbiology room deficient in purification facilities, secondary changing areas, pass-through windows, and material handling ports, impacting operational hygiene and efficiency. Furthermore, the company failed to calibrate essential sterilization equipment, including pressure gauges and differential pressure indicators, and could not provide corresponding calibration certificates, indicating a lapse in equipment maintenance and quality control. Significant problems were also noted in product production records and filing. Specifically, the "Hydrating Eye Essence" product lacked complete production details like production date, batch number, and shelf life. The company also failed to provide batch production and inspection records for this product, which was additionally found to be improperly filed. In response to these findings, the Heilongjiang Provincial Food and Drug Administration has ordered Harbin Michelle Cosmetics Co., Ltd. to implement comprehensive rectification measures within a specified timeframe to address all identified deficiencies.