# China NMPA Drug Inspection - Shaanxi Yishengtang Pharmaceutical Co., Ltd. - Berberine Hydrochloride Tablets

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/shaanxi-yishengtang-pharmaceutical-co-ltd/68c0577c-96c8-4c5d-884c-cf7f7f1fa57d/
Source feed: China

> China NMPA drug inspection for Shaanxi Yishengtang Pharmaceutical Co., Ltd. published December 15, 2021. Drug: Berberine Hydrochloride Tablets. In December 2021, the Heilongjiang Provincial Drug Administration released Announcement No. 16, detailing results from i

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Announcement on Drug Quality Sampling Inspection by Heilongjiang Provincial Drug Administration
- Company Name: Shaanxi Yishengtang Pharmaceutical Co., Ltd.
- Publication Date: 2021-12-15
- Drug Name: Berberine Hydrochloride Tablets
- Inspection Finding: [Content Determination] Unqualified
- Action Taken: Risk control measures such as suspending sales and use will be implemented, investigations will be conducted into the reasons for non-compliance and rectification will be carried out, and illegal acts will be investigated and dealt with in accordance with the law.
- Summary: In December 2021, the Heilongjiang Provincial Drug Administration released Announcement No. 16, detailing results from its annual drug quality sampling inspections of manufacturers, distributors, and healthcare users. The report identified five batches of non-compliant drugs failing to meet safety and quality standards. Involved manufacturers include Bozhou Shantang Traditional Chinese Medicine Pieces Co., Ltd., Anhui Jishantang Traditional Chinese Medicine Technology Co., Ltd., Anhui Mingze Pharmaceutical Co., Ltd., Anhui Hongkun Pharmaceutical Co., Ltd., and Shaanxi Yishengtang Pharmaceutical Co., Ltd. The primary violations involved traditional Chinese medicine pieces and Berberine Hydrochloride Tablets. Inspections revealed failures in physical characteristics and appearance, with some instances of insect infestation specifically attributed to improper storage at the facility level. Additionally, certain batches failed content determination tests, which measure the presence of active ingredients. These evaluations were governed by the Chinese Pharmacopoeia 2015 Edition. In response, the administration has ordered immediate risk control measures, including the suspension of sales and use of the affected products. Companies and medical units are required to investigate the root causes of these failures and implement corrective actions. Regulatory departments are also pursuing legal penalties against entities involved in the production or sale of substandard drugs.

Company: https://www.globalkeysolutions.net/companies/shaanxi-yishengtang-pharmaceutical-co-ltd/0b9c8188-7b96-4233-abbb-42b9c84b8dc2/