# China NMPA Drug Inspection - Jinhe Tibetan Medicine Co., Ltd. - Twenty-Five Flavor Coral Pills

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/jinhe-tibetan-medicine-co-ltd/45791a13-0d0a-4012-9a3a-5067aeac9119/
Source feed: China

> China NMPA drug inspection for Jinhe Tibetan Medicine Co., Ltd. published December 07, 2016. Drug: Twenty-Five Flavor Coral Pills. The China Food and Drug Administration (CFDA) announced on December 7, 2016, critical findings from national drug sampli

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: The State Administration of Drug Administration issued Announcement No. 159 of 2016 regarding the detection of rosin acid or 808 scarlet in 6 batches of drugs from 5 companies including Jilin Yongli Pharmaceutical Co., Ltd.
- Company Name: Jinhe Tibetan Medicine Co., Ltd.
- Publication Date: 2016-12-07
- Drug Name: Twenty-Five Flavor Coral Pills
- Inspection Finding: Detected 808 scarlet
- Action Taken: The Qinghai Provincial Food and Drug Administration has taken product control measures such as sealing and seizing, suspending sales and use, and requiring enterprises to voluntarily recall products. The State Food and Drug Administration has ordered the enterprise to immediately suspend the production of related products, thoroughly investigate the cause of the drug quality problems, and not resume production until the cause is found and rectified. The State Food and Drug Administration has initiated an investigation into the enterprise in accordance with the "Drug Administration Law of the People's Republic of China" and other relevant regulations, and will deal with the matter according to law. If it is found that the Chinese herbal medicine pieces purchased by the enterprise have problems such as illegal dyeing or adulteration, the source must be traced back to the source of the violation. Those suspected of committing crimes should be transferred to the public security organs in a timely manner for criminal prosecution.
- Summary: The China Food and Drug Administration (CFDA) announced on December 7, 2016, critical findings from national drug sampling inspections. Six batches of drugs from five companiesJilin Yongli Pharmaceutical Co., Ltd., Jilin Dongfeng Pharmaceutical Co., Ltd., Jilin Shuangshi Pharmaceutical Co., Ltd., Jinhe Tibetan Medicine Co., Ltd., and Tibet Jinzhu Yalong Tibetan Medicine Co., Ltd.were found to contain unauthorized substances. Specifically, Dieda Huoxue San from Jilin Yongli, Jilin Dongfeng, and Jilin Shuangshi was contaminated with abietic acid (rosin acid), indicating potential raw material adulteration. Ershiwuwei Shanhu Wan from Jinhe Tibetan Medicine and Tibet Jinzhu Yalong Tibetan Medicine contained 808 scarlet, an illegal dye, suggesting potential raw material dyeing. These discoveries highlighted severe deficiencies in the companies' production quality management systems. Regulatory authorities, including provincial and regional Food and Drug Administrations, immediately implemented product control measures such as sealing, seizing, suspending sales, and initiating mandatory recalls. The CFDA mandated that the involved companies cease production of affected products, conduct thorough investigations into the root causes, and implement corrective actions before resuming operations. Further investigations and penalties under the "Drug Administration Law of the People's Republic of China" were ordered. This included tracing the origin of illegal raw materials and referring suspected criminal cases to public security organs, alongside public disclosure of all findings.

Company: https://www.globalkeysolutions.net/companies/jinhe-tibetan-medicine-co-ltd/eb0bcbb3-c288-4587-9774-e4d3656e25d5/