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CHINA DRUG INSPECTION
•Bozhou City Traditional Chinese Medicine Slices Factory

China NMPA Drug Inspection - Bozhou City Traditional Chinese Medicine Slices Factory - Cannon Armor

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Record Details

The Hubei Provincial Food and Drug Administration, operating under the regulatory framework of the National Medical Products Administration (NMPA) and adhering to the "Drug Administration Law of the People's Republic of China," issued a drug quality announcement for the first quarter of 2017. This report, published in October 2019, detailed the findings from sampling inspections conducted across drug production, operation, and use units throughout Hubei Province. A total of 28 batches of drugs from various manufacturers were found to be non-compliant with established quality standards, including the Chinese Pharmacopoeia (2005, 2010, 2015 editions) and Ministry of Health Drug Standards. Violations among Traditional Chinese Medicine (TCM) decoction pieces, which constituted the majority of issues, included failures in properties, identification (e.g., microscopic, thin-layer chromatography), and inspection parameters such as total ash, moisture content, sulfur dioxide residue, and the presence of unapproved coloring agents like tartrazine and acid red 73. For pharmaceutical preparations, non-compliances were identified in areas like content weight variation, microbial limits, and dissolution rates. City and prefecture food and drug administration departments are mandated to investigate and address these non-compliant drugs and implicated units. Actions include thoroughly tracing the source of drugs without clear purchase channels or from unverified manufacturers. Cases where criminal activity is suspected are to be promptly transferred to public security authorities for prosecution, underscoring a stringent enforcement approach.

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Bozhou City Traditional Chinese Medicine Slices Factory
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ID · 57dd40de-515e-47e8-a953-1580d7552743

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