# China NMPA Drug Inspection - Henan Hongbo Pharmaceutical Co., Ltd. - Diclofenac sodium enteric-coated tablets

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/henan-hongbo-pharmaceutical-co-ltd/84501d3d-6500-4e78-8526-cc83014f21f3/
Source feed: China

> China NMPA drug inspection for Henan Hongbo Pharmaceutical Co., Ltd. published January 18, 2013. Drug: Diclofenac sodium enteric-coated tablets. The State Food and Drug Administration (SFDA) of China issued a National Drug Quality Bulletin on January 18, 2013, deta

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: National Drug Quality Bulletin (Issue 6, 2012, Serial No. 94)
- Company Name: Henan Hongbo Pharmaceutical Co., Ltd.
- Publication Date: 2013-01-18
- Drug Name: Diclofenac sodium enteric-coated tablets
- Inspection Finding: Release rate does not meet regulations
- Action Taken: Investigate and punish according to law
- Summary: The State Food and Drug Administration (SFDA) of China issued a National Drug Quality Bulletin on January 18, 2013, detailing findings from national drug sampling inspections conducted throughout 2012. The regulatory review targeted 17 essential drug varieties and 3 other pharmaceutical preparations, totaling 20 different drug types. Inspections revealed critical quality control deficiencies, with 37 batches of products failing to meet established standards across numerous pharmaceutical manufacturers. Primary violations included non-compliance with microbial limits, inaccuracies in active ingredient content assay (e.g., for Chenpi, Panax notoginseng, Morphine), and improper drug release rates for enteric-coated formulations such as Diclofenac Sodium and Omeprazole. Issues with incorrect quantities or dosages in injections (e.g., Glucose, Sodium Chloride), as well as ethanol content and activity assays, were also identified. These non-conformities were evaluated against the Chinese Pharmacopoeia, Ministry of Health Drug Standards, and National Drug Standards. The SFDA mandated that provincial food and drug administration departments investigate the implicated drugs and manufacturers, requiring submission of their findings by February 20, 2013, to ensure appropriate corrective actions and public drug safety.

Company: https://www.globalkeysolutions.net/companies/henan-hongbo-pharmaceutical-co-ltd/2943054c-bff0-45e0-9f8d-6d42678a3dac/