# China NMPA Drug Inspection - Jilin Yizheng Pharmaceutical Group Co., Ltd. - Roxithromycin tablets

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/jilin-yizheng-pharmaceutical-group-co-ltd/039459ad-8632-4111-a23c-8bf0114d3fe5/
Source feed: China

> China NMPA drug inspection for Jilin Yizheng Pharmaceutical Group Co., Ltd. published September 14, 2017. Drug: Roxithromycin tablets. An announcement published on September 14, 2017, by the State Administration for Market Regulation (NMPA), detailed find

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Announcement No. 149 of 2017 from the State Administration for Market Regulation regarding 6 batches of substandard drugs.
- Company Name: Jilin Yizheng Pharmaceutical Group Co., Ltd.
- Publication Date: 2017-09-14
- Drug Name: Roxithromycin tablets
- Inspection Finding: The non-compliant items included microbial limits and dissolution rate.
- Action Taken: Relevant provincial food and drug administrations have taken control measures such as sealing and seizing goods, requiring companies to suspend sales and use, recall products, and rectify the situation. The State Food and Drug Administration has ordered investigations into illegal activities involving the production and sale of substandard drugs, and to publicly disclose the results within three months.
- Summary: An announcement published on September 14, 2017, by the State Administration for Market Regulation (NMPA), detailed findings of substandard drugs from two manufacturers. Based on tests by two drug testing institutions, including the Dalian Municipal Institute for Drug Control, six batches of products were identified as non-compliant. Sanmenxia Guangyu Biopharmaceutical Co., Ltd. was cited for five batches of its Qinghouyan Mixture (batch numbers 161001, 161003, 161004, 161103, and 161201) failing to meet microbial limits. Additionally, Jilin Jingxin Pharmaceutical Group Co., Ltd.'s Roxithromycin Tablets (batch number 20160802) exhibited an unsatisfactory dissolution rate. In response to these issues, provincial food and drug administrations took immediate control measures, including sealing and seizing the affected drugs. The involved companies were mandated to suspend sales and use of the products, initiate recalls, and implement necessary corrective actions. Furthermore, provincial regulators were instructed to investigate these violations in accordance with Articles 73, 74, and 75 of the "Drug Administration Law of the People's Republic of China." They are required to publicly disclose the investigation outcomes within three months and report their findings to the State Food and Drug Administration, ensuring compliance and safeguarding public health.

Company: https://www.globalkeysolutions.net/companies/jilin-yizheng-pharmaceutical-group-co-ltd/afb19f34-04a4-40de-a7d6-3e78bbabaa93/