# China NMPA Drug Inspection - Bozhou Shenghai Traditional Chinese Medicine Decoction Pieces Co., Ltd. - Sophora tonkinensis

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/bozhou-shenghai-traditional-chinese-medicine-decoction-pieces-co-ltd/e9dc65cf-bbfc-4eb4-8147-f19f05aee253/
Source feed: China

> China NMPA drug inspection for Bozhou Shenghai Traditional Chinese Medicine Decoction Pieces Co., Ltd. published November 26, 2024. Drug: Sophora tonkinensis. On November 26, 2024, the National Medical Products Administration (NMPA) issued Announcement No. 51, reporting that 28 

---

## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Announcement No. 51 of 2024 from the National Medical Products Administration regarding 28 batches of drugs that did not meet the requirements.
- Company Name: Bozhou Shenghai Traditional Chinese Medicine Decoction Pieces Co., Ltd.
- Publication Date: 2024-11-26
- Drug Name: Sophora tonkinensis
- Inspection Finding: [Content Determination]
- Action Taken: Drug regulatory authorities have required relevant enterprises and units to take risk control measures such as suspending sales and use and recalling products, to investigate the reasons for non-compliance and to make effective rectifications; the National Medical Products Administration has required relevant provincial drug regulatory authorities to organize investigations into the suspected illegal activities of the aforementioned enterprises and units in accordance with the "Drug Administration Law of the People's Republic of China" and to disclose the results of the investigations as required.
- Summary: On November 26, 2024, the National Medical Products Administration (NMPA) issued Announcement No. 51, reporting that 28 batches of drugs from 23 enterprises failed to meet quality standards. Comprehensive testing by nine drug testing institutions identified a range of significant quality control issues. Key violations included visible foreign matter in acyclovir eye drops from companies like Shijiazhuang Green Pharmaceutical Co., Ltd. and Guangdong Hengjian Pharmaceutical Co., Ltd. Other critical deficiencies involved incorrect levels of acrolein, glucose, and ammonium salts in glycerin-containing enema from Jingzhou Jinfeng Pharmaceutical Development Co., Ltd., and substandard related substances in phenylpropanolamine phosphate oral solution by Shaanxi Guanai Pharmaceutical Co., Ltd. Issues with fill volume were noted for econazole nitrate cream and cold and fever relieving granules. Traditional Chinese Medicine preparations, such as safflower from multiple manufacturers including Hangzhou Kanglun, exhibited unacceptable appearance, while others like Albizia julibrissin flowers and Sophora tonkinensis root had impurities or failed content determination. Operating under the "Drug Administration Law of the People's Republic of China" and national drug standards, the NMPA has mandated immediate risk control measures. These include suspending sales and use, product recalls, and thorough investigations into the root causes of non-compliance. Furthermore, provincial drug regulatory authorities are required to investigate suspected illegal activities and publicly disclose their findings, ensuring accountability and corrective action across the pharmaceutical sector.

Company: https://www.globalkeysolutions.net/companies/bozhou-shenghai-traditional-chinese-medicine-decoction-pieces-co-ltd/6d262dd8-43ca-4a7a-8a97-cc5e3a1f488f/