# China NMPA Drug Inspection - Tonghua Renmin Pharmaceutical Co., Ltd. - Weikangling Capsules

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/tonghua-renmin-pharmaceutical-co-ltd/57c338f1-fddf-4c2f-866a-e7ec3241cf06/
Source feed: China

> China NMPA drug inspection for Tonghua Renmin Pharmaceutical Co., Ltd. published December 23, 2015. Drug: Weikangling Capsules. The State Food and Drug Administration (SFDA) of China issued an announcement on December 23, 2015, detailing non-compli

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Announcement No. 104 of 2015 from the State Food and Drug Administration regarding multiple batches of products from Guangxi Rongren Pharmaceutical Co., Ltd. and Tonghua Limin Pharmaceutical Co., Ltd. that failed to meet regulations.
- Company Name: Tonghua Renmin Pharmaceutical Co., Ltd.
- Publication Date: 2015-12-23
- Drug Name: Weikangling Capsules
- Inspection Finding: Microbial limits not in compliance with regulations
- Action Taken: Immediately take recall measures, initiate an investigation, suspend production for rectification, thoroughly investigate the cause of the quality problem, and formulate corrective measures.
- Summary: The State Food and Drug Administration (SFDA) of China issued an announcement on December 23, 2015, detailing non-compliance found during national drug sampling inspections affecting Guangxi Rongren Pharmaceutical Co., Ltd. and Tonghua Limin Pharmaceutical Co., Ltd. Guangxi Rongren Pharmaceutical Co., Ltd. had ten batches of its Pediatric Antipyretic Oral Liquid fail content determination tests, specifically regarding the active components Gardenia and Scutellaria baicalensis, as per the Pharmacopoeia of the People's Republic of China 2010 Edition. Tonghua Limin Pharmaceutical Co., Ltd. had three batches of its Weikangling Capsules fail microbial limits tests, also against the 2010 Pharmacopoeia. These findings reflect significant quality management issues within both companies. Under the regulatory oversight of the SFDA, the Jilin Provincial and Guangxi Zhuang Autonomous Region Food and Drug Administrations were instructed to supervise immediate recall efforts for all affected products. The companies are required to halt production for comprehensive rectification, thoroughly investigate the root causes of the quality deficiencies, and implement effective corrective actions. Regulatory bodies in distribution areas are mandated to ensure the removal and sealing of non-compliant drugs from shelves. Public disclosure of recall and investigation progress is also a key requirement.

Company: https://www.globalkeysolutions.net/companies/tonghua-renmin-pharmaceutical-co-ltd/c90209df-9299-4d6a-a972-455fb0b6b7f5/