# China NMPA Inspection - Guangxi Jianyi Pharmaceutical Co., Ltd. Traditional Chinese Medicine Processing Plant - March 27, 2015

Source: https://www.globalkeysolutions.net/records/china_inspection/guangxi-jianyi-pharmaceutical-co-ltd-traditional-chinese-medicine-processing-plant/1c8a8628-bff0-4d80-aba1-de7ce155c70e/
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> China NMPA unannounced inspection for Guangxi Jianyi Pharmaceutical Co., Ltd. Traditional Chinese Medicine Processing Plant published March 27, 2015. An unannounced inspection of Guangxi Jianyi Pharmaceutical Co., Ltd.'s traditional Chinese medicine processing plant, conducted by the State Food and 

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## Details

- Record Type: CHINA_INSPECTION
- Title: Surprise inspection of the traditional Chinese medicine processing plant of Guangxi Jianyi Pharmaceutical Co., Ltd.
- Company Name: Guangxi Jianyi Pharmaceutical Co., Ltd. Traditional Chinese Medicine Processing Plant
- Publication Date: 2015-03-27
- Product Type: Drugs
- Summary: An unannounced inspection of Guangxi Jianyi Pharmaceutical Co., Ltd.'s traditional Chinese medicine processing plant, conducted by the State Food and Drug Administration and Guangxi Zhuang Autonomous Region Food and Drug Administration from March 2nd to 4th, 2015, uncovered severe non-compliance with the Drug Administration Law and Good Manufacturing Practice (GMP) regulations. Key violations included the suspected issuance of false invoices, facilitating illegal operations for other pharmaceutical companies by invoicing for traditional Chinese medicine varieties far exceeding documented production and inspection capacities. Sales records for some products, like Sophora flavescens, lacked corresponding warehousing entries. The company also falsified numerous production and inspection records, showing inconsistencies in batch numbers, production dates, and equipment operation logs. Toxic materials, such as black aconite, were present in the finished product warehouse without proper documentation. Laboratory records were deficient in reagent preparation logs and sample retention. Equipment inadequacies were significant; essential processing equipment was missing or non-functional, environmental controls for material storage were absent, and a new high-performance liquid chromatograph remained unused. Consequently, Guangxi Jianyi Pharmaceutical Co., Ltd. was ordered to cease production and sales and recall all affected Chinese herbal medicine pieces. Investigations are underway to revoke its drug production license, and cases involving suspected criminal activity have been referred to public security authorities.

Company: https://www.globalkeysolutions.net/companies/guangxi-jianyi-pharmaceutical-co-ltd-traditional-chinese-medicine-processing-plant/96310956-4bc6-49fa-b866-0f5a3120d648/