# China NMPA Drug Inspection - Shanxi Wanglong Pharmaceutical Group Co., Ltd. - Gastrodia capsules

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/shanxi-wanglong-pharmaceutical-group-co-ltd/b82f8217-ba82-4f72-95e4-79b1465e58f9/
Source feed: China

> China NMPA drug inspection for Shanxi Wanglong Pharmaceutical Group Co., Ltd. published December 24, 2021. Drug: Gastrodia capsules. On December 24, 2021, the Sichuan Provincial Drug Administration issued Announcement No. 14, identifying 15 batches of p

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Sichuan Provincial Drug Administration Announcement Regarding 15 Batches of Drugs That Failed to Meet Regulations (No. 14 of 2021)
- Company Name: Shanxi Wanglong Pharmaceutical Group Co., Ltd.
- Publication Date: 2021-12-24
- Drug Name: Gastrodia capsules
- Inspection Finding: Properties and moisture content do not meet the requirements
- Action Taken: Relevant enterprises and units have been required to take risk control measures such as suspending sales and use and recalling products, investigate the reasons for non-compliance and make effective rectifications; cases have been filed for investigation and the results of the investigation and handling have been made public in accordance with regulations.
- Summary: On December 24, 2021, the Sichuan Provincial Drug Administration issued Announcement No. 14, identifying 15 batches of pharmaceutical products from 15 companies that failed to meet quality standards. The inspections, conducted by various regional institutes, involved manufacturers such as Guangxi Jinye Pharmaceutical Co., Ltd., Shanxi Wanglong Pharmaceutical Group, Inner Mongolia Haitian Pharmaceutical, and several Sichuan-based traditional medicine producers like Sichuan Tianfu Shenlong and Sichuan Hongpu Pharmaceutical.

The primary violations identified during testing included physical defects such as improper appearance, excessive moisture content, and weight variations. More significant safety and efficacy issues were also noted, including excessive impurities in traditional Chinese medicine pieces, sulfur dioxide residues, and failures in 'content determination,' where products lacked the required levels of active medicinal ingredients like emodin or rutin.

Operating under the framework of the Drug Administration Law of the People's Republic of China, the regulatory authority has mandated immediate corrective actions. The involved companies must implement risk control measures, including the suspension of sales and the mandatory recall of all substandard batches. Furthermore, the companies are required to investigate the root causes of these quality failures and perform comprehensive rectifications. Local regulatory departments have been directed to initiate formal investigations into the production and sale of these substandard drugs, with the results to be disclosed to the public.

Company: https://www.globalkeysolutions.net/companies/shanxi-wanglong-pharmaceutical-group-co-ltd/0cc2e93a-1884-4f7b-a94f-80a49f7c77fe/