# China NMPA Drug Inspection - Anhui Bozhou Sanzhen Traditional Chinese Medicine Pieces Co., Ltd. (Origin: Zhejiang) - Ume

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/anhui-bozhou-sanzhen-traditional-chinese-medicine-pieces-co-ltd-origin-zhejiang/b48f299f-4e46-45fe-ad75-38f749a1d4ca/
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> China NMPA drug inspection for Anhui Bozhou Sanzhen Traditional Chinese Medicine Pieces Co., Ltd. (Origin: Zhejiang) published September 21, 2019. Drug: Ume. The Henan Provincial Drug Administration issued an announcement on September 21, 2019, detailing findings of seven batch

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Announcement from Henan Provincial Drug Administration Regarding 7 Batches of Substandard Drugs (No. 11, 2019)
- Company Name: Anhui Bozhou Sanzhen Traditional Chinese Medicine Pieces Co., Ltd. (Origin: Zhejiang)
- Publication Date: 2019-09-21
- Drug Name: Ume
- Inspection Finding: The non-compliant item is appearance.
- Action Taken: The Henan Provincial Drug Administration has instructed relevant drug regulatory departments to take necessary risk control measures such as sealing, seizing, and suspending sales of substandard drugs, and to investigate and punish the units that source the samples in accordance with the law.
- Summary: The Henan Provincial Drug Administration issued an announcement on September 21, 2019, detailing findings of seven batches of substandard drugs from six manufacturers. Companies implicated include Anhui Yaozhiyuan Traditional Chinese Medicine Pieces Co., Ltd., Anhui Xiehecheng Pharmaceutical Pieces Co., Ltd., Anhui Bozhou Sanzhen Traditional Chinese Medicine Pieces Co., Ltd., Guizhou Bailing Enterprise Group Zhengxin Pharmaceutical Co., Ltd., Bozhou Changsheng Traditional Chinese Medicine Pieces Co., Ltd., and Maoming Junbang Traditional Chinese Medicine Pieces Co., Ltd. The main issues identified were quality deficiencies, with several traditional Chinese medicine products like Prunus mume, Evodia rutaecarpa, Sangjisheng, and Zaojiaoci failing appearance tests. Additionally, Norfloxacin capsules were found non-compliant due to a failed dissolution rate. These inspections were conducted under the regulatory framework of the Chinese Pharmacopoeia (2010 and 2015 editions) and other approved testing methods. As a result, the Administration mandated immediate risk control actions, including sealing, seizing, and suspending sales of the affected drug batches. Furthermore, regulatory departments were instructed to investigate and penalize the responsible units to ensure adherence to quality standards.

Company: https://www.globalkeysolutions.net/companies/anhui-bozhou-sanzhen-traditional-chinese-medicine-pieces-co-ltd-origin-zhejiang/1b09131e-4bfb-4b00-988a-26a71ff42d65/