# China NMPA Drug Inspection - Qinhuangdao Dexin Pharmaceutical Co., Ltd. - Traditional Chinese medicine decoction pieces, including Bupleurum root and Typha pollen.

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/qinhuangdao-dexin-pharmaceutical-co-ltd/f0600bd7-b53d-4f87-9abf-b5a2ef2bb31f/
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> China NMPA drug inspection for Qinhuangdao Dexin Pharmaceutical Co., Ltd. published November 18, 2019. Drug: Traditional Chinese medicine decoction pieces, including Bupleurum root and Typha pollen.. The Shandong Provincial Food and Drug Administration issued an announcement in May 2017, later publicized in November 20

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Announcement from Shandong Provincial Food and Drug Administration Regarding 41 Batches of Chinese Herbal Medicine Pieces Failing Quality Inspection (Issue 3, 2017)
- Company Name: Qinhuangdao Dexin Pharmaceutical Co., Ltd.
- Publication Date: 2019-11-18
- Drug Name: Traditional Chinese medicine decoction pieces, including Bupleurum root and Typha pollen.
- Inspection Finding: 41 batches of 28 types of TCM decoction pieces were found to be unqualified. Unqualified items included assay and characters.
- Action Taken: Relevant city food and drug administration bureaus implemented control measures such as seizure, detention, suspension of sales, and product recall. Enterprises were investigated and dealt with according to laws and regulations. The NMPA will strengthen follow-up inspections and sampling, and local bureaus are required to strengthen daily supervision, urge enterprises to identify the root causes, formulate and implement rectification measures, and eliminate risk hazards.
- Summary: The Shandong Provincial Food and Drug Administration issued an announcement in May 2017, later publicized in November 2019, detailing significant compliance issues within the Traditional Chinese Medicine (TCM) sector. This announcement, identified as Issue 3, 2017, reported that 41 batches of TCM decoction pieces, encompassing 28 different types including Bupleurum chinense and Typha orientalis, were found to be substandard or unqualified. These findings were based on tests conducted by nine drug testing institutions. The deficiencies were identified across products from 27 different enterprises, including notable companies such as Anguo Hongfa Traditional Chinese Medicine Slices Co., Ltd., Anhui Bozhou Sanzhen Traditional Chinese Medicine Slices Co., Ltd., and Bozhou Boyaotang Pharmaceutical Co., Ltd. The regulatory framework under which these issues were addressed involved the Shandong Provincial Food and Drug Administration exercising its supervisory authority. In response, immediate control measures were implemented by relevant municipal food and drug administrations. These actions included sealing and seizing non-compliant products, suspending sales, and initiating recalls. Furthermore, investigations were launched into the manufacturers and units involved in the sampling process, with enforcement taken in accordance with applicable laws and regulations. The provincial administration also committed to strengthening follow-up inspections and random checks. Additionally, municipal bureaus were tasked with enhancing daily supervision, prompting enterprises to identify root causes of non-compliance, develop and implement effective rectification plans, and mitigate future risks.

Company: https://www.globalkeysolutions.net/companies/qinhuangdao-dexin-pharmaceutical-co-ltd/dec24f53-5193-4549-8e92-7386d7ffd795/