# China NMPA Drug Inspection - Sichuan Tianzhi Traditional Chinese Medicine Co., Ltd. - mugwort

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/sichuan-tianzhi-traditional-chinese-medicine-co-ltd/06970226-7a13-4858-9b03-ef1a163980cd/
Source feed: China

> China NMPA drug inspection for Sichuan Tianzhi Traditional Chinese Medicine Co., Ltd. published November 22, 2019. Drug: mugwort. The Chongqing Municipal Drug Administration, in an announcement dated November 22, 2019, reported significant quality co

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Announcement from Chongqing Municipal Drug Administration Regarding 45 Batches of Drugs That Failed to Meet Regulations
- Company Name: Sichuan Tianzhi Traditional Chinese Medicine Co., Ltd.
- Publication Date: 2019-11-22
- Drug Name: mugwort
- Inspection Finding: Content determination did not meet the requirements
- Action Taken: The Chongqing Municipal Drug Administration has instructed its relevant directly affiliated inspection bureaus and district/county market supervision bureaus to take necessary control measures such as sealing, seizing, suspending sales, and recalling products, and to investigate and deal with the matter in accordance with relevant laws and regulations.
- Summary: The Chongqing Municipal Drug Administration, in an announcement dated November 22, 2019, reported significant quality control failures involving 45 batches of drugs, predominantly traditional Chinese medicine products and raw materials. These non-compliant items were sourced from 28 companies, including Chengdu Jiankang Pharmaceutical Co., Ltd., Yibin Renhe Traditional Chinese Medicine Pieces Co., Ltd., and various suppliers in the Chongqing Traditional Chinese Medicine Professional Market. Inspections by five regional drug testing institutions identified a range of critical violations against established quality standards. Primary issues included "Content Determination" failures, meaning products like Mulberry leaves, Oyster, and Epimedium brevicornu lacked the specified active ingredient levels crucial for efficacy. Many products also did not meet "Appearance/Properties" standards, exhibiting issues such as mold on Anemarrhena asphodeloides, or failing "Identification" tests, raising concerns about authenticity for items like Cremastra appendiculata. Furthermore, "Inspection" criteria were violated, indicating deficiencies in purity, uniformity, or presence of excessive impurities (e.g., sulfur dioxide residue), while some products like Hydrangea macrophylla contained excessive "Extractives." The regulatory framework for these assessments primarily consisted of the Chinese Pharmacopoeia (2015 and 2010 editions) and specific provincial/municipal processing standards for traditional Chinese medicine. As a result of these findings, the Administration has mandated immediate regulatory actions. These include sealing, seizing, suspending sales, and recalling all identified non-compliant drugs, with further legal enforcement to follow.

Company: https://www.globalkeysolutions.net/companies/sichuan-tianzhi-traditional-chinese-medicine-co-ltd/217ae077-bb4a-43ee-975a-55b300e39bcd/