China NMPA Inspection - Shenzhen Heshuntang Pharmaceutical Co., Ltd. - August 24, 2018

Shenzhen Heshuntang Pharmaceutical Co., Ltd. underwent an unannounced inspection by the State Food and Drug Administration's Verification Center from June 21-23, 2018. This annual inspection aimed to assess compliance with national pharmaceutical business enterprise standards. Several significant violations of Good Supply Practice (GSP) for pharmaceuticals were identified. Inspectors found pharmaceutical products, including Poria cocos slices, tortoise shell glue, and deer antler glue, stored at an address not approved by the company's Drug Business License. Furthermore, the company's computer management system failed to restrict sales operations for customers whose qualifications had expired. Shenzhen Heshuntang also neglected to conduct mandatory internal audits following critical organizational changes, such as the change in quality manager and registered address. Additional findings included the storage of Dragon's blood in a non-pharmaceutical area, and deficiencies in the traditional Chinese medicine material warehouse, where processed herbs were found in the waiting area, and temperature and humidity monitoring terminals were absent. These actions constituted a serious breach of regulatory requirements. Consequently, the National Medical Products Administration (NMPA) directed the Guangdong Provincial Food and Drug Administration to revoke Shenzhen Heshuntang Pharmaceutical Co., Ltd.'s GSP certification. An investigation into the company's suspected illegal and irregular business practices has also been initiated.