# China NMPA Drug Inspection - Inner Mongolia Haitian Pharmaceutical Co., Ltd. - Xindakang tablets

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/inner-mongolia-haitian-pharmaceutical-co-ltd/a883e8e5-27ca-4264-8a63-cbb0d6d512bf/
Source feed: China

> China NMPA drug inspection for Inner Mongolia Haitian Pharmaceutical Co., Ltd. published December 24, 2021. Drug: Xindakang tablets. On December 24, 2021, the Sichuan Provincial Drug Administration released an announcement identifying 15 batches of phar

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Announcement from Sichuan Provincial Drug Administration Regarding 15 Batches of Drugs That Failed to Meet Regulations
- Company Name: Inner Mongolia Haitian Pharmaceutical Co., Ltd.
- Publication Date: 2021-12-24
- Drug Name: Xindakang tablets
- Inspection Finding: The non-compliant item is the property.
- Action Taken: Risk control measures such as suspending sales and use, recalling products, investigating the reasons for non-compliance and making concrete rectifications, and the drug regulatory authorities will initiate an investigation.
- Summary: On December 24, 2021, the Sichuan Provincial Drug Administration released an announcement identifying 15 batches of pharmaceutical products from 15 different companies that failed to meet national quality standards. Key companies involved include Guangxi Jinye Pharmaceutical Co., Ltd., Shanxi Wanglong Pharmaceutical Group, Inner Mongolia Haitian Pharmaceutical, and several traditional Chinese medicine (TCM) suppliers such as Sichuan Tianfu Shenlong and Yibin Renhe. 

The inspections, conducted by various municipal testing centers, revealed several violations. Main issues identified included substandard appearance, excessive moisture content, and weight variations in capsules and tablets. TCM products specifically failed due to the presence of medicinal debris, impurities, excessive sulfur dioxide residue, and insufficient active ingredient levels (content determination). For instance, Niuhuang Jiedu Tablets were flagged for improper emodin levels, while various Epimedium batches contained excessive impurities.

These products were evaluated under the regulatory framework of the Drug Administration Law of the People's Republic of China and the 2015 Edition of the Chinese Pharmacopoeia. In response to these violations, the authorities have mandated immediate risk control measures, including the suspension of all sales and the mandatory recall of the non-compliant batches. The involved manufacturers are required to investigate the root causes of these quality failures and implement effective corrective actions. Additionally, local regulatory departments have been ordered to initiate legal investigations into the production and sale of these substandard drugs, with results to be disclosed to the public.

Company: https://www.globalkeysolutions.net/companies/inner-mongolia-haitian-pharmaceutical-co-ltd/50d5033e-2268-4441-b270-aeca4b71a572/