# China NMPA Drug Inspection - Harbin Huarui Biochemical Pharmaceutical Co., Ltd. - Fluconazole capsules

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/harbin-huarui-biochemical-pharmaceutical-co-ltd/878ed05f-5201-4b77-b8aa-3d54531dd0af/
Source feed: China

> China NMPA drug inspection for Harbin Huarui Biochemical Pharmaceutical Co., Ltd. published February 01, 2018. Drug: Fluconazole capsules. The Heilongjiang Provincial Food and Drug Administration issued an announcement on January 29, 2018, detailing findings 

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Announcement from the Heilongjiang Provincial Food and Drug Administration regarding 14 batches of substandard drugs (preparations) (Issue No. 2, 2018)
- Company Name: Harbin Huarui Biochemical Pharmaceutical Co., Ltd.
- Publication Date: 2018-02-01
- Drug Name: Fluconazole capsules
- Inspection Finding: The non-compliant items were inspection, content determination, appearance, identification, etc.
- Action Taken: Relevant food and drug administration departments have taken control measures such as sealing and seizing the substandard drugs, and have supervised the suspension of sales and use of this batch of products for rectification. Meanwhile, the provincial bureau has ordered an investigation into the illegal sale of substandard drugs and a public disclosure of the results within a specified timeframe.
- Summary: The Heilongjiang Provincial Food and Drug Administration issued an announcement on January 29, 2018, detailing findings from quality testing of pharmaceutical products. Testing conducted by institutions including the Heilongjiang Provincial Food and Drug Inspection and Testing Institute revealed that 14 batches of drugs and preparations from 13 different companies, including Suicheng Pharmaceutical Co., Ltd., were substandard. Identified issues spanned various quality parameters, specifically failing tests related to inspection, content determination, appearance, and identification. In response, regulatory authorities implemented immediate control measures, including the sealing and seizure of affected products. The sampled units were instructed to cease the sale and use of these batches and to initiate corrective actions. Furthermore, municipal food and drug administration departments were mandated to investigate the illegal distribution of these substandard drugs. These investigations are to be conducted in accordance with Articles 73, 74, and 75 of the Drug Administration Law of the People's Republic of China. A requirement was set for the public disclosure of handling results for the involved enterprises and units within three months, with prompt reporting to the Provincial Bureau. This initiative underscores the provincial administration's commitment to upholding drug quality and ensuring public safety.

Company: https://www.globalkeysolutions.net/companies/harbin-huarui-biochemical-pharmaceutical-co-ltd/e7febb87-c93e-4e84-aead-ae4f4f4889a7/