# China NMPA Drug Inspection - Guangxi Jiajin Pharmaceutical Co., Ltd. - Kang Erxin Capsules

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/guangxi-jiajin-pharmaceutical-co-ltd/bdb6a9bb-9b1e-4f1c-93ad-07ae31124d88/
Source feed: China

> China NMPA drug inspection for Guangxi Jiajin Pharmaceutical Co., Ltd. published November 03, 2016. Drug: Kang Erxin Capsules. The State Food and Drug Administration (SFDA) announced critical findings from follow-up sampling inspections conducted 

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Announcement No. 144 of 2016 from the State Administration for Market Regulation regarding the failure of five batches of drugs from three companies, including Guizhou Tiandi Pharmaceutical Co., Ltd., to pass follow-up sampling inspections.
- Company Name: Guangxi Jiajin Pharmaceutical Co., Ltd.
- Publication Date: 2016-11-03
- Drug Name: Kang Erxin Capsules
- Inspection Finding: Kang'erxin capsules were found to have substandard content determination during follow-up sampling inspections, and the company had previously failed to meet the standards in sampling inspections, reflecting significant problems in its production quality management.
- Action Taken: The Guangxi Provincial Food and Drug Administration has taken product control measures such as sealing and seizing, ordering recalls, and suspending sales and use; ordered the suspension of production of related products, and prohibits the resumption of production until the cause of the drug quality problems is thoroughly investigated and rectified; filed a case against the company, will deal with it seriously in accordance with the law, and listed it as a key regulatory target.
- Summary: The State Food and Drug Administration (SFDA) announced critical findings from follow-up sampling inspections conducted prior to October 31, 2016. These inspections revealed repeated quality failures in drug products from three pharmaceutical companies, indicating significant deficiencies in their production quality management systems.

Guizhou Tiandi Pharmaceutical Co., Ltd. had three batches (15070702A, 15070703A, 15070804A) of Dexamethasone Sodium Phosphate Injection found substandard due to issues with related substances. Guangxi Ditai Pharmaceutical Co., Ltd.'s Kang'erxin Capsules (batch 150501) failed content determination. Furthermore, Hunan Yige Pharmaceutical Co., Ltd.'s Transfer Factor (batch 150706) was found to be non-sterile. These findings represent a recurrence of issues previously identified in national drug sampling inspections.

Under the "Drug Administration Law of the People's Republic of China," the SFDA has mandated stringent actions. Provincial food and drug administrations in Guizhou, Guangxi, and Hunan have initiated product control measures, including sealing, seizing, recalling, and suspending the sale and use of the affected drugs. The companies are required to immediately cease production of the relevant products, thoroughly investigate and rectify the root causes of the quality problems, and are prohibited from resuming production until full compliance is achieved. The SFDA will pursue legal investigations against these companies, enforce penalties, publicly disclose information, and designate them as priority targets for ongoing supervision.

Company: https://www.globalkeysolutions.net/companies/guangxi-jiajin-pharmaceutical-co-ltd/9f463ccb-ccf8-4a3e-8b4e-25d0a4668c51/