# China NMPA Drug Inspection - Sichuan Tianyun Minkang Traditional Chinese Medicine Pieces Co., Ltd. - Psoralea corylifolia

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/sichuan-tianyun-minkang-traditional-chinese-medicine-pieces-co-ltd/e2c69019-7eb9-46e4-b948-7429a9d5ee1a/
Source feed: China

> China NMPA drug inspection for Sichuan Tianyun Minkang Traditional Chinese Medicine Pieces Co., Ltd. published August 16, 2019. Drug: Psoralea corylifolia. The Sichuan Provincial Drug Administration published a bulletin on August 16, 2019, detailing the outcomes of its 2019 d

---

## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Sichuan Province Drug Quality Bulletin (Fourth Issue, 2019)
- Company Name: Sichuan Tianyun Minkang Traditional Chinese Medicine Pieces Co., Ltd.
- Publication Date: 2019-08-16
- Drug Name: Psoralea corylifolia
- Inspection Finding: [Content determination] (Total amount of psoralen and isopsoralen)
- Action Taken: The relevant drug regulatory authorities have investigated and dealt with the matter in accordance with laws and regulations, and have required the relevant companies to suspend sales and use, recall products, conduct investigations into the reasons for non-compliance, and carry out thorough rectification.
- Summary: The Sichuan Provincial Drug Administration published a bulletin on August 16, 2019, detailing the outcomes of its 2019 drug sampling inspection program. These inspections, carried out across drug production, distribution, and use facilities throughout Sichuan Province, uncovered 23 batches of non-compliant drugs. Manufacturers identified in the violations include Jingfukang Pharmaceutical Group, Sichuan Wuzhi Traditional Chinese Medicine, Sichuan Kangquantang, and Sichuan Tuojiangyuan Pharmaceutical Co., Ltd., among others. The primary issues, assessed against the Chinese Pharmacopoeia 2015 Edition Part I, largely revolved around failures in content determination, indicating discrepancies in active ingredient quantities for various products like Shenling Baizhu Powder and Epimedium. Additional violations included unacceptable levels of extractives, erroneous drug identification through microscopic analysis or thin-layer chromatography, and excessive moisture or total ash content. In response, the regulatory authorities have initiated enforcement actions. The implicated companies are required to halt sales and use of the affected products, implement recalls, thoroughly investigate the underlying causes of non-compliance, and undertake comprehensive corrective measures to resolve the identified quality deficiencies.

Company: https://www.globalkeysolutions.net/companies/sichuan-tianyun-minkang-traditional-chinese-medicine-pieces-co-ltd/acc3930c-7414-41f7-b975-efda320d5419/