# China NMPA Drug Inspection - Hebei Qixin Traditional Chinese Medicine Granules and Slices Co., Ltd. - Vinegar-processed Schisandra chinensis

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/hebei-qixin-traditional-chinese-medicine-granules-and-slices-co-ltd/6d233dbe-eedf-451b-b231-4e06f8601635/
Source feed: China

> China NMPA drug inspection for Hebei Qixin Traditional Chinese Medicine Granules and Slices Co., Ltd. published June 04, 2018. Drug: Vinegar-processed Schisandra chinensis. The Ningxia Food and Drug Administration, operating under China's National Medical Products Administration (NMPA) framew

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Ningxia Drug Quality Sampling Inspection Information Announcement (No. 03, 2018)
- Company Name: Hebei Qixin Traditional Chinese Medicine Granules and Slices Co., Ltd.
- Publication Date: 2018-06-04
- Drug Name: Vinegar-processed Schisandra chinensis
- Inspection Finding: The indicated manufacturer did not produce this batch of medicine, leading to non-compliance in its appearance/properties.
- Action Taken: The non-compliant drugs have been investigated and dealt with by the relevant city and county market supervision administrations according to law.
- Summary: The Ningxia Food and Drug Administration, operating under China's National Medical Products Administration (NMPA) framework, published an announcement on June 4, 2018, detailing regional drug quality sampling inspection results. The inspection campaign covered 92 batches of 31 different drug varieties, including chemical drugs and traditional Chinese medicines. A total of 7 varieties from 8 batches were found to be non-compliant with established quality standards, primarily the Chinese Pharmacopoeia 2015 Edition, Part I. Significant issues included cases where the indicated manufacturer, such as Hebei Qixin Traditional Chinese Medicine Granules and Slices Co., Ltd., Ningxia Mingde Traditional Chinese Medicine Slices Co., Ltd., and Shaanxi Xiangju Pharmaceutical Group Co., Ltd., did not produce the respective batches of "Clematis chinensis," "Eriocaulon buergerianum," "Lysimachia christinae," and "Safflower." This raises serious concerns about product authenticity and supply chain control. Additionally, quality control failures were identified. Ningxia Mingde Traditional Chinese Medicine Slices Co., Ltd.'s "Dioscorea opposita" exceeded total ash content limits. Batches of "Citron" from Anhui Shitian Traditional Chinese Medicine Pieces Co., Ltd. and Ningxia Baicaowang Pharmaceutical Co., Ltd. failed appearance standards. The problematic "Safflower" batch also demonstrated non-compliance in appearance, total ash, and acid-insoluble ash. Regulatory authorities have mandated investigations and appropriate legal actions by local market supervision administrations to ensure rectification and maintain drug quality and safety.

Company: https://www.globalkeysolutions.net/companies/hebei-qixin-traditional-chinese-medicine-granules-and-slices-co-ltd/743c36a8-2b56-4fa6-a05a-00ffafb5ec40/