# China NMPA Drug Inspection - Shenwei Pharmaceutical Group Co., Ltd. - Fried jujube seed formula granules

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/shenwei-pharmaceutical-group-co-ltd/5b84760d-924f-4315-af06-fcd0c5a0d565/
Source feed: China

> China NMPA drug inspection for Shenwei Pharmaceutical Group Co., Ltd. published November 09, 2023. Drug: Fried jujube seed formula granules. On November 9, 2023, the China National Medical Products Administration (NMPA) issued Announcement No. 57 regarding qual

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Announcement No. 57 of 2023 from the National Medical Products Administration regarding one batch of drugs that did not meet the requirements.
- Company Name: Shenwei Pharmaceutical Group Co., Ltd.
- Publication Date: 2023-11-09
- Drug Name: Fried jujube seed formula granules
- Inspection Finding: Microbial limits not in compliance with regulations
- 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; relevant provincial drug regulatory authorities have organized investigations into suspected illegal activities of relevant enterprises and units and have made the results of the investigations public in accordance with regulations.
- Summary: On November 9, 2023, the China National Medical Products Administration (NMPA) issued Announcement No. 57 regarding quality control failures at Shenwei Pharmaceutical Group Co., Ltd. The announcement followed testing by the Zhejiang Provincial Institute for Food and Drug Control, which identified that one batch of the company's stir-fried jujube seed formula granules failed to meet national safety regulations. Specifically, the product exceeded established microbial limits, indicating potential hygiene or contamination issues during the manufacturing process. This enforcement action was conducted under the 'Drug Administration Law of the People's Republic of China.' In response to the findings, regulatory authorities have mandated immediate risk control measures, including the suspension of all sales and usage of the affected batch and the initiation of a comprehensive product recall. Shenwei Pharmaceutical Group is required to conduct an internal investigation to identify the root cause of the non-compliance and implement corrective actions. Furthermore, provincial authorities will pursue legal investigations into the company's activities and are required to publicly disclose the final results of these inquiries to ensure transparency and public safety.

Company: https://www.globalkeysolutions.net/companies/shenwei-pharmaceutical-group-co-ltd/44d8928b-957f-4cfc-bd95-1aae462198da/