# China NMPA Drug Inspection - Ningxia Kangtailong Traditional Chinese Medicine Pieces Co., Ltd. - Epimedium

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/ningxia-kangtailong-traditional-chinese-medicine-pieces-co-ltd/a0182c34-b87d-499d-90d4-37b14fe29fda/
Source feed: China

> China NMPA drug inspection for Ningxia Kangtailong Traditional Chinese Medicine Pieces Co., Ltd. published September 12, 2019. Drug: Epimedium. The Sichuan Provincial Drug Administration, in adherence to its 2019 Drug Sampling Inspection Work Plan, performed compr

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Sichuan Provincial Drug Administration's Sichuan Provincial Drug Quality Bulletin (Fifth Issue, 2019)
- Company Name: Ningxia Kangtailong Traditional Chinese Medicine Pieces Co., Ltd.
- Publication Date: 2019-09-12
- Drug Name: Epimedium
- Inspection Finding: [Content Determination] (Epimedium glycoside)
- Action Taken: The sale and use of the products were suspended, the products were recalled, an investigation was conducted into the reasons for non-compliance, and thorough rectification measures were implemented.
- Summary: The Sichuan Provincial Drug Administration, in adherence to its 2019 Drug Sampling Inspection Work Plan, performed comprehensive quality inspections on various drug production, distribution, and use units. This initiative culminated in an announcement on September 10, 2019, identifying 19 batches of non-compliant drugs from multiple manufacturers, including Qinghai Chaidamu High-Tech Pharmaceutical, Neijiang Baishengtang Pharmaceutical, and Sichuan Tuojiangyuan Pharmaceutical, among others.The inspections, conducted against the stringent standards of the Chinese Pharmacopoeia (2015 Edition), uncovered a range of quality control deficiencies. These issues encompassed problems with drug appearance, moisture content, disintegration time, total ash and acid-insoluble ash levels, inaccurate identification, inconsistent extractive content, and deviations in the quantitative determination of active ingredients such as iron salt, atractylodes, coltone, curculigo glycoside, curculigo orchioides, and epimedium.In response, the regulatory authorities have issued clear directives to the affected companies. Required actions include the immediate suspension of sales and use of the identified non-compliant batches, comprehensive product recalls, thorough investigations into the root causes of these quality failures, and the implementation of robust and complete rectification measures to ensure future compliance and safeguard public health.

Company: https://www.globalkeysolutions.net/companies/ningxia-kangtailong-traditional-chinese-medicine-pieces-co-ltd/a694531f-2c50-42fd-8fde-65ee24abca7e/