# China NMPA Drug Inspection - Jiangxi Pinxin Pharmaceutical Co., Ltd. - Gynecological Leukorrhea Relief Tablets

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/jiangxi-pinxin-pharmaceutical-co-ltd/732bb7da-0b3b-44f5-b96d-3e4127213a7e/
Source feed: China

> China NMPA drug inspection for Jiangxi Pinxin Pharmaceutical Co., Ltd. published January 13, 2016. Drug: Gynecological Leukorrhea Relief Tablets. The State Food and Drug Administration (SFDA) announced on January 13, 2016, findings from national drug sampling inspec

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Announcement No. 4 of 2016 from the State Food and Drug Administration regarding multiple batches of products from four companies, including Haikou Pharmaceutical Factory Co., Ltd., that failed to meet regulations.
- Company Name: Jiangxi Pinxin Pharmaceutical Co., Ltd.
- Publication Date: 2016-01-13
- Drug Name: Gynecological Leukorrhea Relief Tablets
- Inspection Finding: Content determination did not meet the requirements
- Action Taken: Local drug regulatory authorities have ordered companies to suspend sales and immediately recall substandard batches of products, and are further investigating and prosecuting the companies involved. The National Medical Products Administration has instructed local drug regulatory authorities to supervise companies in recalling substandard drugs already on the market, promptly disclose recall information, and ensure that recalls are carried out effectively. They have also instructed companies to suspend production of the affected products, thoroughly investigate the causes of the drug quality problems, formulate corrective measures based on the identified causes, and implement effective rectification.
- Summary: The State Food and Drug Administration (SFDA) announced on January 13, 2016, findings from national drug sampling inspections revealing multiple batches of non-compliant products from four pharmaceutical companies. The implicated companies are Haikou Pharmaceutical Factory Co., Ltd., Hainan Lingkang Pharmaceutical Co., Ltd., Anhui Tongtai Pharmaceutical Co., Ltd., and Jiangxi Minji Pharmaceutical Co., Ltd. Main violations included Haikou Pharmaceutical Factory's cefamandole sodium for injection failing identification, pH, and content determination. Hainan Lingkang Pharmaceutical had cefamandole sodium for injection batches failing clarity, color, and volume variation, and meclofenac hydrochloride for injection batches failing fill weight variation and content determination. Anhui Tongtai and Jiangxi Minji Pharmaceutical both had multiple batches of gynecological anti-leukorrhea tablets failing content determination. These widespread deficiencies indicate systemic issues in the companies' quality management and production process control. Under the SFDA's directive, provincial Food and Drug Administrations were mandated to oversee immediate actions. These actions include ordering the companies to suspend sales, recall all substandard products, and conduct thorough investigations into the root causes of the quality failures. Furthermore, companies must halt production of the affected items, develop and implement effective rectification measures, and publicly disclose all relevant recall and investigation information. Local regulatory bodies are responsible for supervising distributors and users to ensure the prompt removal and sealing of non-compliant drugs, aiding in the recall process.

Company: https://www.globalkeysolutions.net/companies/jiangxi-pinxin-pharmaceutical-co-ltd/bdb1ef72-0c91-401f-9c5b-1a9deab9a631/