China NMPA Inspection - Jiangsu Jiaoyan Barbie Cosmetics Co., Ltd. - July 24, 2020

The National Medical Products Administration (NMPA) conducted a surprise inspection of Jiangsu Jiaoyan Barbie Cosmetics Co., Ltd., with findings announced on July 24, 2020. The inspection revealed severe non-compliance with the "Cosmetics Production Licensing Work Specifications," indicating significant deficiencies across the company's quality management system.

Key violations included a lack of essential laboratory equipment, such as a centrifuge for required testing, and absent environmental monitoring records for the microbiology lab. The company failed to establish quality standards for critical raw materials like Elderberry Extract and Sophora flavescens Root Extract, neglecting to test them. Finished product inspection reports and original records were missing for items like Lolo Forest Infant Elderberry Nourishing Essence Cream. Furthermore, there were no records for standard solution preparation or culture media, and the quality management department did not properly authorize material releases. Non-conforming materials were improperly stored and unlabeled, and raw material batch numbers were absent in production records, hindering traceability.

Facility issues included unauthorized use of building space for storage, inadequate environmental monitoring in the production workshop since 2018, and poor equipment hygiene, with internal parts of filling machines remaining uncleaned. Supplier management was absent, leading to unverified raw material sourcing, and significant inventory discrepancies were noted. Materials were improperly stored, with temperature-sensitive items exposed to 30℃. Production practices posed contamination risks, and crucially, no system for monitoring or reporting adverse product reactions was in place.

As a result, the NMPA has ordered a complete suspension of cosmetic production at Jiangsu Jiaoyan Barbie Cosmetics Co., Ltd. The company must undertake comprehensive rectification and pass a follow-up inspection by the Jiangsu Provincial Medical Products Administration before any production can resume, with legal action pending for suspected illegal activities.