# China NMPA Drug Inspection - Shanxi Fenhe Pharmaceutical Co., Ltd. - Vitamin B1 tablets

Source: https://www.keypedia.com/records/china_drug_inspection/shanxi-fenhe-pharmaceutical-co-ltd/bde00f00-04c5-499a-9c5b-a290ec703a1e
Source feed: China

> China NMPA drug inspection for Shanxi Fenhe Pharmaceutical Co., Ltd. published March 25, 2020. Drug: Vitamin B1 tablets. On March 25, 2020, the Jiangxi Provincial Drug Administration (NMPA) released its second 2020 drug inspection announceme

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Jiangxi Province 2020, Second Quarter Drug Supervision and Sampling Inspection Information Announcement
- Company Name: Shanxi Fenhe Pharmaceutical Co., Ltd.
- Publication Date: 2020-03-25
- Drug Name: Vitamin B1 tablets
- Inspection Finding: [Inspection] - Related substances do not meet regulations
- Action Taken: Necessary control measures such as sealing, seizing, suspending sales, and recalling products will be implemented, and the production enterprises and sampled units will be investigated and dealt with in accordance with relevant laws and regulations.
- Summary: On March 25, 2020, the Jiangxi Provincial Drug Administration (NMPA) released its second 2020 drug inspection announcement, detailing quality failures across 33 batches of 30 drug varieties. The inspections, conducted under the framework of the Chinese Drug Administration Law and the 2015 Chinese Pharmacopoeia, identified significant quality control issues at several firms, including Xiangyu Pharmaceutical Co., Ltd., Shanxi Fenhe Pharmaceutical, and Guangdong Bozhou Pharmaceutical. The primary violations involved technical failures such as 'content determination' (incorrect amounts of active ingredients), 'weight variation' (inconsistency in tablet size), and excessive 'related substances' (impurities). Other notable issues included failed dissolution tests, excessive moisture content, and deviations in physical appearance and characteristics. In response, the Jiangxi Provincial Drug Administration has mandated immediate regulatory actions. Authorities have instructed relevant departments to seal and seize the affected products, suspend all sales, and initiate recalls of non-compliant batches. Furthermore, the administration has launched formal investigations into the manufacturers and distributors involved to determine legal penalties and ensure future adherence to national safety standards.

Company: https://www.keypedia.com/companies/shanxi-fenhe-pharmaceutical-co-ltd/6562f037-885e-4c29-8755-ac30d32e3af4