China NMPA Inspection - Tianjin Shiwen Cosmetics Co., Ltd. - December 13, 2017

An unannounced inspection by the National Food and Drug Administration and the Tianjin Municipal Market and Quality Supervision and Management Commission was conducted at Tianjin Shiwen Cosmetics Co., Ltd. on December 5, 2017. The inspection, based on the "Key Points for Cosmetics Production License Inspection," identified several significant non-conformities across multiple operational areas.

In laboratory management, the company's internal control standards for microbial testing, specifically total bacterial count, mold, and yeast, diverged from the 2015 "Cosmetics Safety Technical Specifications" without supporting comparative verification data or scientific justification. Plant and facility management issues included the storage of a drum of decamethylcyclopentasiloxane, a flammable liquid, in the base material manufacturing workshop's weighing room, with inadequate warning labels regarding flammability and safe handling.

Material management revealed several deficiencies. The company failed to provide an inspection report for glycerin used in an eyebrow powder stick and lacked supplier qualification documents and established supplier files. Additionally, a substantial quantity of raw materials was temporarily stored in the workshop without essential labeling details such as supplier code, delivery date, production date, or inventory quantity. A significant discrepancy was also found between the ledger and actual physical quantity for the raw material Tocopherol. Finally, product filing management was non-compliant, as filed product registration materials were not archived according to the "Notice on Adjusting Relevant Matters Concerning the Registration and Filing Management of Cosmetics" (No. 10 of 2013).

As a result, the Tianjin Municipal Market and Quality Supervision and Management Commission has been directed to mandate prompt rectification of all identified issues by Tianjin Shiwen Cosmetics Co., Ltd., with subsequent reporting to the State Administration for Market Regulation upon completion.