China NMPA Inspection - Guangxi Shibiao Pharmaceutical Co., Ltd. - July 03, 2018

An unannounced inspection of Guangxi Shibiao Pharmaceutical Co., Ltd., conducted as part of a drug tracking plan and published on July 3, 2018, uncovered significant non-compliance with the Good Manufacturing Practice for Pharmaceuticals (2010 Revision). The inspection identified critical deficiencies primarily in the company's Banlangen tablets production workshop. Main violations included a substandard cleanroom environment (Line C) with issues such as sunken floors, rust, mold, corroded equipment, faulty check valves, and the use of fiber-shedding cotton work clothes. Furthermore, the production process for Banlangen tablets lacked periodic re-verification, and the storage time for Banlangen viscous paste remained unverified. Serious issues were also found in computerized analytical instrument procedures, with no established protocols for personnel login, authorization, or data control, and undefined authority levels. Document and record management were inadequate, evidenced by outdated forms, unapproved handwritten operating procedures, incomplete product quality review reports, and missing information on raw material labels. Consequently, the Guangxi Zhuang Autonomous Region Food and Drug Administration was instructed to revoke the company's relevant GMP certificates and initiate a legal investigation into the identified illegal activities.