China NMPA Inspection - Xinhua County Zhenyu Bioengineering Co., Ltd. - June 26, 2019

An unannounced inspection of Xinhua County Zhenyu Bioengineering Co., Ltd. was conducted on June 11-12, 2019, by the Hunan Provincial Drug Administration. This supervision inspection, based on "Cosmetic Hygiene Supervision Regulations" and related licensing standards, uncovered multiple significant violations of "Cosmetic Production Licensing Work Specifications."

Key issues included the production manager's unfamiliarity with cosmetic laws and responsibilities, and the absence of quality standard documents for raw and packaging materials. The microbiology testing laboratory environment was deemed unsuitable due to a lack of sterilization and ventilation facilities. Warehouse management deficiencies involved improper stacking, missing rodent/insect screens at ventilation openings, and a lack of clear zoning for inspection, qualified, and unqualified finished products.

Furthermore, critical records were incomplete or missing, such as batch production records (specifically cleaning and ingredient preparation), material requisition records, and records for cleaning and disinfection of inner packaging materials. Raw materials requiring cool storage were also not maintained under specified conditions.

Consequently, the company received a rectification order from the Hunan Provincial Drug Administration, mandating that all identified deficiencies be corrected within a defined timeframe, and a rectification report submitted upon completion.