# China NMPA Drug Inspection - Jilin Jichun Pharmaceutical Co., Ltd. - Gynecological Leukorrhea Relief Tablets

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/jilin-jichun-pharmaceutical-co-ltd/780a7308-36b4-4563-a278-8270e8f3934d/
Source feed: China

> China NMPA drug inspection for Jilin Jichun Pharmaceutical Co., Ltd. published March 14, 2016. Drug: Gynecological Leukorrhea Relief Tablets. On March 14, 2016, China's State Administration for Market Regulation (NMPA) issued Announcement No. 54, revealing criti

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: State Administration of Drug Administration Announcement No. 54 of 2016: 36 batches of drugs from 29 companies including Suzhou Sinochem Pharmaceutical Industry Co., Ltd. were found to be substandard.
- Company Name: Jilin Jichun Pharmaceutical Co., Ltd.
- Publication Date: 2016-03-14
- Drug Name: Gynecological Leukorrhea Relief Tablets
- Inspection Finding: The product was found to be substandard after testing. The substandard items included dissolution rate, related substances, bacterial count, clarity and color of the solution, visible foreign matter, disintegration time, moisture content, fill volume variation, weight variation, and content determination.
- Action Taken: The company was ordered to suspend production and sales, immediately recall products, and the relevant companies were instructed to thoroughly investigate the cause, initiate an investigation, and handle the matter according to law.
- Summary: On March 14, 2016, China's State Administration for Market Regulation (NMPA) issued Announcement No. 54, revealing critical quality deficiencies identified during national drug sampling inspections. The announcement detailed that 36 batches of drugs from 29 pharmaceutical companies, including Suzhou Zhonghua Pharmaceutical Industry Co., Ltd., were found to be substandard.

Prominent issues included quality failures in products such as Itraconazole capsules from Suzhou Zhonghua, Meclofenac Hydrochloride for Injection from Nanjing Haichen Pharmaceutical Co., Ltd., and Gastrodia elata headache tablets from Harbin Renhuang Pharmaceutical Co., Ltd. The non-compliant aspects spanned critical quality attributes, including dissolution rate, presence of related substances, bacterial count, solution clarity, visible foreign matter, disintegration time, moisture content, and variations in fill volume and weight, indicating significant manufacturing control problems.

Under the NMPA's regulatory authority, provincial food and drug administrations in 16 regions were mandated to take immediate action. This involved requiring the affected enterprises to suspend production and sales, initiate product recalls, and conduct comprehensive investigations into the root causes of the quality deviations. Companies were also instructed to address these issues legally, with results of investigations and handling required to be publicly disclosed by May 31, 2016, and reported back to the NMPA.

Company: https://www.globalkeysolutions.net/companies/jilin-jichun-pharmaceutical-co-ltd/84771b47-8aa9-48ed-aab2-fd7f24e016f0/