China NMPA Inspection - Hunan Haiji Biotechnology Co., Ltd. - June 26, 2019

Hunan Haiji Biotechnology Co., Ltd. was subject to an unannounced supervisory inspection by the Hunan Provincial Drug Administration on June 11-12, 2019. This inspection, carried out under the framework of the "Cosmetic Hygiene Supervision Regulations" and "Key Points for Cosmetic Production License Inspection," uncovered multiple significant non-conformities.

The main issues identified included pervasive deficiencies in batch production records, which lacked crucial elements such as prior cleaning records, intermediate product inspection reports, and coding information. Operational records for preparation and filling stations were incomplete, omitting details on critical control points like feeding sequence, temperature, and stirring parameters. Additionally, original inspection records were found to be untraceable due to missing sample batch numbers, inspection methodologies, and equipment details. Infrastructure concerns were also present, specifically damaged floors within the workshop's airlock and cleaning areas. Process specifications for products, such as sheep placenta extract skincare liquid, were incomplete, lacking essential weighing operation requirements and critical control points. Finally, cleaning and disinfection records for inner packaging materials were inadequate, lacking proper verification and showing inconsistencies with established documentation.

These findings indicated that the company violated the requirements outlined in the "Cosmetic Production Licensing Work Specifications." Consequently, the Hunan Provincial Drug Administration issued a rectification order, requiring Hunan Haiji Biotechnology Co., Ltd. to address all identified deficiencies within a specified period and submit a comprehensive report detailing the corrective actions taken upon completion.