# China NMPA Drug Inspection - Henan Qianfang Pharmaceutical Co., Ltd. - Clematis

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/henan-qianfang-pharmaceutical-co-ltd/4beaa176-8704-4d5c-bf75-d0d058323c8b/
Source feed: China

> China NMPA drug inspection for Henan Qianfang Pharmaceutical Co., Ltd. published August 28, 2020. Drug: Clematis. On August 28, 2020, the Henan Provincial Drug Administration published its third announcement of 2020 regarding seven ba

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Announcement from Henan Provincial Drug Administration Regarding 7 Batches of Substandard Drugs (Issue 3, 2020)
- Company Name: Henan Qianfang Pharmaceutical Co., Ltd.
- Publication Date: 2020-08-28
- Drug Name: Clematis
- Inspection Finding: [Properties], [Identification] - (2) Thin-layer chromatography does not meet the requirements
- Action Taken: Relevant drug regulatory authorities have been organized to take control measures and investigate and punish the substandard drugs in accordance with the law, and have required the relevant enterprises or units to take risk control measures such as suspending sales, use or recall, investigate the reasons for the substandard products, and make sure to rectify them.
- Summary: On August 28, 2020, the Henan Provincial Drug Administration published its third announcement of 2020 regarding seven batches of substandard drugs discovered during annual sampling inspections across production and distribution channels. The inspections identified non-compliant products from manufacturers including Henan Qianfang Pharmaceutical Co., Ltd., Wugang Hongkang Pharmaceutical Co., Ltd., and Anguo Changda Traditional Chinese Medicine Pieces Co., Ltd. One batch labeled as Anhui Meiyu Traditional Chinese Medicine Pieces Co., Ltd. was also flagged, though the company denied manufacturing it.

The violations primarily involved failures to meet standards set by the Chinese Pharmacopoeia (2015 Edition, Part I). Specific quality issues included failed property and identification tests, excessive sulfur dioxide residues, high levels of impurities and total ash, and inadequate content determination for active ingredients like berberine. In response to these findings, the regulatory authority has ordered involved entities to immediately suspend the sale and use of affected products and initiate mandatory recalls. Furthermore, the companies must conduct thorough investigations into the root causes of these quality failures and implement comprehensive rectification measures to ensure future compliance and protect public health.

Company: https://www.globalkeysolutions.net/companies/henan-qianfang-pharmaceutical-co-ltd/2baae642-2af9-458a-a3df-84e56fa775a5/