# China NMPA Drug Inspection - Shandong Kongshengtang Pharmaceutical Co., Ltd. - Chest-opening and Qi-regulating pills

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/shandong-kongshengtang-pharmaceutical-co-ltd/1ab0ee5a-f05e-467e-acab-a8775088b9e9/
Source feed: China

> China NMPA drug inspection for Shandong Kongshengtang Pharmaceutical Co., Ltd. published January 12, 2018. Drug: Chest-opening and Qi-regulating pills. On January 11, 2018, the China Food and Drug Administration (CFDA), now known as the National Medical Products Administr

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Announcement No. 15 of 2018 from the State Administration for Market Regulation regarding 20 batches of substandard drugs.
- Company Name: Shandong Kongshengtang Pharmaceutical Co., Ltd.
- Publication Date: 2018-01-12
- Drug Name: Chest-opening and Qi-regulating pills
- Action Taken: Relevant provincial food and drug administration departments have taken control measures such as sealing and seizing goods, requiring the company to suspend sales and use, recall products, and rectify the situation. The local provincial food and drug administration department has initiated an investigation into the company in accordance with the "Drug Administration Law of the People's Republic of China" and will publicly disclose the results within three months and promptly report to the State Administration for Market Regulation.
- Summary: On January 11, 2018, the China Food and Drug Administration (CFDA), now known as the National Medical Products Administration (NMPA), issued an announcement (No. 15 of 2018) detailing findings from drug quality testing. Inspections conducted by nine drug testing institutions revealed that 20 batches of drugs from 16 different pharmaceutical companies were substandard. Key manufacturers identified include Wuhan Hualong Biopharmaceutical Co., Ltd., Shaanxi Panlong Pharmaceutical Group Co., Ltd., Changchun Yinnuoke Pharmaceutical Co., Ltd., and several others. The main quality control violations varied across products but frequently involved critical parameters such as disintegration time, loss on drying, fill weight variation, related substances, moisture content, and microbial limits. For instance, Somatostatin for Injection from Wuhan Hualong showed issues with related substances, while various 'Kaixiong Shunqi pills' batches had problems with moisture or microbial limits. In response, provincial food and drug administration departments immediately implemented control measures, including sealing and seizing affected products, ordering a suspension of sales and use, product recalls, and mandatory rectification by the companies. Operating under the Drug Administration Law of the People's Republic of China, specifically Articles 73, 74, and 75, the CFDA mandated that provincial authorities investigate these illegal activities. Companies were required to publicly disclose their handling results within three months and report back to the CFDA, ensuring accountability and adherence to national drug quality standards.

Company: https://www.globalkeysolutions.net/companies/shandong-kongshengtang-pharmaceutical-co-ltd/e4cabc65-a72e-4238-9a21-59ad39ccbc3b/