# China NMPA Drug Inspection - Guangdong Yifang Pharmaceutical Co., Ltd - Isatis root injection

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/guangdong-yifang-pharmaceutical-co-ltd/c71eaa58-14b0-45d9-85c0-1daabe8b1e13/
Source feed: China

> China NMPA drug inspection for Guangdong Yifang Pharmaceutical Co., Ltd published August 06, 2019. Drug: Isatis root injection. The Guizhou Provincial Drug Administration released an announcement on August 6, 2019, detailing the outcomes of its dru

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Guizhou Provincial Drug Administration Drug Sampling Inspection Information Bulletin, Issue 2, 2019
- Company Name: Guangdong Yifang Pharmaceutical Co., Ltd
- Publication Date: 2019-08-06
- Drug Name: Isatis root injection
- Inspection Finding: Non-compliance with regulations: Under the "Inspection" section: Visible foreign objects
- Action Taken: Drug regulatory authorities at all levels are investigating and handling the matter in accordance with the law, and have taken timely control measures against the relevant drugs.
- Summary: The Guizhou Provincial Drug Administration released an announcement on August 6, 2019, detailing the outcomes of its drug quality sampling inspections conducted under the 2019 provincial plan. These inspections aimed to bolster drug quality oversight and safeguard public health. The regulatory framework for these assessments included the Chinese Pharmacopoeia 2015 Edition, Part I, and Volume 20 of Traditional Chinese Medicine Compound Preparations. Three distinct batches of drugs were identified as failing to meet required standards.

Key violations include: Jiangxi Shunfutang Traditional Chinese Medicine Pieces Co., Ltd.'s "Salt-processed Morinda officinalis" was non-compliant with its specified properties. Anshun Changshou Xinxin Traditional Chinese Medicine Development Co., Ltd.'s "Lycium chinense root bark" failed the "Total Ash" inspection, suggesting purity issues. Most critically, Guangdong Xinfeng Pharmaceutical Co., Ltd.'s "Isatis indigotica root injection" was found to contain visible foreign matter, a significant quality defect for an injectable product.

In response to these findings, drug regulatory departments at all levels are actively investigating the non-compliant products and their manufacturers. Legal actions are being pursued against the implicated entities, and prompt control measures have been initiated for all affected drugs to mitigate public health risks.

Company: https://www.globalkeysolutions.net/companies/guangdong-yifang-pharmaceutical-co-ltd/07846ca9-3cec-469c-8361-754173210343/