China NMPA Drug Inspection - Guangxi Yulin Huaantang Traditional Chinese Medicine Pieces Co., Ltd. - Galangal

The Guangxi Zhuang Autonomous Region Food and Drug Administration released a Drug Quality Announcement (Issue 44) on May 3, 2017, outlining findings from its comprehensive drug sampling inspection program. This initiative aimed to bolster drug quality oversight and ensure public medication safety across its jurisdiction, encompassing drug manufacturers, distributors, and medical facilities. The inspections were conducted in adherence to the Guangxi Drug Sampling Inspection Plan, various editions of the Chinese Pharmacopoeia, and regional Traditional Chinese Medicine processing specifications.

The announcement detailed six batches of drugs found to be substandard. Specific issues included "Visible foreign matter" in Vitamin B6 Injection from Guangdong Nanguo Pharmaceutical Co., Ltd., and an aberrant "Characteristic chromatogram" for Antiviral Oral Liquid manufactured by Wuhan Jinlian Pharmaceutical Co., Ltd. Compound Berberine Tablets from Yunnan Mingjing Hengli Pharmaceutical Co., Ltd. failed on "Appearance." For Traditional Chinese Medicine decoction pieces, *Chuanposhi* from Guangxi Renjitang Traditional Chinese Medicine Decoction Pieces Co., Ltd. was non-compliant in "Properties," while Galangal and Fritillaria thunbergii from Guangxi Yulin Zhizhen Traditional Chinese Medicine Medicinal Pieces Co., Ltd. failed "Content Determination" and "Dioxide" specifications, respectively.

In response to these violations, the regulatory authorities have mandated immediate control measures, including the sealing, seizing, suspending sales of, and recalling of the affected drugs. Furthermore, legal investigations and appropriate penalties are being pursued against the entities responsible for the non-compliant samples.