China NMPA Drug Inspection - Anhui Jin Furong Traditional Chinese Medicine Tablets Co., Ltd. - Isatis root
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On February 9, 2017, China's State Administration for Market Regulation announced findings from drug testing institutions, revealing that 54 batches of traditional Chinese medicine decoction pieces from 46 companies, including Shanghai Huaying Pharmaceutical Co., Ltd., were substandard. Key violations encompassed deficiencies in product appearance, content determination, identification, and elevated sulfur dioxide residue, indicating non-compliance with the standards outlined in the *Pharmacopoeia of the People's Republic of China*. Specific issues involved Banlangen (Isatis root) and Angelica sinensis exhibiting multiple quality failures, Magnolia officinalis (Houpu) having improper content determination, and Scorpion (Quan Xie) failing on extractives. Operating under the 'Drug Administration Law of the People's Republic of China,' provincial food and drug administrations were mandated to implement immediate control measures. These included sealing and seizing products, suspending sales and usage, and initiating recalls. Additionally, administrations are required to investigate the illegal production and sale activities, issue penalty decisions within one month, report findings to the State Food and Drug Administration, and publicly disclose the penalties, which must also target responsible individuals. A process was also established for companies to challenge product authenticity, leading to further investigation and potential severe sanctions if claims are disproven.
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