China NMPA Inspection - Roppongi Cosmetics (Dalian) Co., Ltd. - October 10, 2017

An unannounced inspection of Roppongi Cosmetics (Dalian) Co., Ltd. was conducted on September 13, 2017, by the National Food and Drug Administration and the Liaoning Provincial Food and Drug Administration. The inspection, based on "Key Points for Cosmetics Production License Inspection," revealed numerous deficiencies across several key operational areas.

Significant issues were identified in laboratory management, including the absence of environmental control equipment in the microbiology lab, incomplete original inspection records lacking crucial details like testing methods, judgment criteria, and equipment information, and uncalibrated testing equipment. Material and product release procedures were not consistently followed, and fundamental plant facilities, such as the production workshop and warehouses, lacked essential rodent-proof measures.

Further non-compliance included the absence of equipment status labels for production and filling machinery, uncalibrated production equipment, and a lack of water system sampling points for water treatment. Material and product management was inadequate, with raw material purchase records missing batch numbers and the warehouse lacking designated areas for material statuses. The production process lacked a material input verification step, and a specific finished product (batch 170322) showed discrepancies between its production records and formulation. Additionally, product sales records were incomplete, missing vital batch number information.

As a result, the Liaoning Provincial Food and Drug Administration was directed to mandate that Roppongi Cosmetics rectify all identified problems within a specified timeframe. Following the company's completion of these corrective actions, the provincial administration is required to report the outcome to the Drug and Chemical Supervision Department of the State Administration for Market Regulation.