# China NMPA Drug Inspection - Hubei Guangji Pharmaceutical Co.,Ltd. - Stir-fried peach kernels

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/hubei-guangji-pharmaceutical-coltd/1a5bf6ae-a6e7-4628-91f1-d47e13314feb/
Source feed: China

> China NMPA drug inspection for Hubei Guangji Pharmaceutical Co.,Ltd. published July 27, 2017. Drug: Stir-fried peach kernels. 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: Hubei Guangji Pharmaceutical Co.,Ltd.
- Publication Date: 2017-07-27
- Drug Name: Stir-fried peach kernels
- Inspection Finding: Properties and identification (microscopic characteristics)
- Action Taken: In accordance with the provisions of the "Drug Administration Law of the People's Republic of China", this matter will be investigated and dealt with.
- 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/hubei-guangji-pharmaceutical-coltd/00d8ea96-ff48-4ee4-b62d-87ed188cc450/