China NMPA Inspection - Guangzhou Jiuhong Pharmaceutical Technology Co., Ltd. - April 19, 2018

Guangzhou Jiuhong Pharmaceutical Technology Co., Ltd. was subjected to an unannounced inspection by the National Food and Drug Administration and the Guangdong Provincial Food and Drug Administration on March 28-29, 2018. The inspection, conducted under the "Key Points for Cosmetic Production License Inspection," identified 16 defects, including 8 serious violations of the "Cosmetic Production Licensing Work Specifications." Significant issues were found across several operational areas. Personnel problems included a lack of qualified inspection staff, expired health certificates for key personnel, and production hygiene lapses. Quality management was severely compromised by missing batch production and inspection records for recent products, inadequate raw material and finished product inspections, expired equipment calibrations, and poorly labeled semi-finished products, making product traceability impossible. Facility-related issues involved an inoperative air purification system, expired cleanroom and water quality test reports, and a lack of maintenance records for equipment and the water system. Material handling was also deficient, with improper storage and labeling of raw materials and inadequate retention samples. Additionally, essential production process records and recent sales documentation were absent. Consequently, the Guangdong Provincial Food and Drug Administration ordered Guangzhou Jiuhong Pharmaceutical Technology Co., Ltd. to immediately suspend all cosmetic production and sales. Operations can only resume after all deficiencies are fully rectified and confirmed by the Guangdong Provincial Food and Drug Administration, with a report submitted to the State Drug Administration.