# China NMPA Drug Inspection - Shanxi Tongda Pharmaceutical Co., Ltd. - Pinellia ternata

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/shanxi-tongda-pharmaceutical-co-ltd/eec8819a-aa25-4722-a6bf-56b914469d3a/
Source feed: China

> China NMPA drug inspection for Shanxi Tongda Pharmaceutical Co., Ltd. published July 27, 2017. Drug: Pinellia ternata. The Hubei Provincial Food and Drug Administration announced on July 27, 2017, findings from drug quality sampling inspec

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Hubei Province Drug Quality Bulletin (Issue 2, 2017)
- Company Name: Shanxi Tongda Pharmaceutical Co., Ltd.
- Publication Date: 2017-07-27
- Drug Name: Pinellia ternata
- Inspection Finding: Properties and identification (thin-layer chromatography)
- Action Taken: To trace the source of the problematic drugs, a thorough investigation must be conducted; those suspected of committing crimes should be promptly transferred to the public security organs for criminal prosecution.
- Summary: The Hubei Provincial Food and Drug Administration announced on July 27, 2017, findings from drug quality sampling inspections conducted during the second quarter of 2017. These inspections identified 30 batches of non-compliant drugs from various manufacturers, distributors, and users across the province. Key companies implicated included Wuhu Kangqi Pharmaceutical Co., Ltd. and Shandong Yikang Pharmaceutical Co., Ltd., whose Vitamin K1 Injection batches failed related substances and content determination tests. A critical finding was the discovery of "counterfeit" drugs, such as Osteoarthritis Capsules and Compound Cough and Asthma Relief Capsules, containing undeclared substances like Prednisolone Acetate. Additionally, batches of Nifedipine Sustained-Release Tablets (II), attributed to Qingdao Huanghai Pharmaceutical Co., Ltd., were non-compliant for content determination, with the manufacturer denying production. Violations covered a broad spectrum of quality parameters, including dissolution, related substances, content accuracy, pH, weight variation, physical properties, moisture content, microbial contamination, and identification. The regulatory framework for these actions is primarily the "Drug Administration Law of the People's Republic of China," supported by the Chinese Pharmacopoeia and various national and provincial drug standards. Required actions mandate local food and drug administrations to investigate, take enforcement actions, report findings to the Provincial Bureau, trace the origins of problematic drugs, and transfer suspected criminal cases to public security organs for prosecution, ensuring drug safety and compliance.

Company: https://www.globalkeysolutions.net/companies/shanxi-tongda-pharmaceutical-co-ltd/3219b4f1-95e8-4c5d-837f-1a4d50c3d120/