# China NMPA Inspection - Guangxi Xinlong Pharmaceutical Co., Ltd. - September 30, 2017

Source: https://www.globalkeysolutions.net/records/china_inspection/guangxi-xinlong-pharmaceutical-co-ltd/6776d4bd-de5f-4dc3-b942-05fb044867ae/
Source feed: China

> China NMPA unannounced inspection for Guangxi Xinlong Pharmaceutical Co., Ltd. published September 30, 2017. An unannounced inspection of Guangxi Xinlong Pharmaceutical Co., Ltd. conducted by the State Food and Drug Administration's Verification Center and th

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Guangxi Xinlong Pharmaceutical Co., Ltd.
- Company Name: Guangxi Xinlong Pharmaceutical Co., Ltd.
- Publication Date: 2017-09-30
- Product Type: Drugs
- Summary: An unannounced inspection of Guangxi Xinlong Pharmaceutical Co., Ltd. conducted by the State Food and Drug Administration's Verification Center and the Guangxi Zhuang Autonomous Region Food and Drug Administration from August 22-24, 2017, revealed serious quality management issues. The inspection, prompted by a complaint, focused on Compound Danshen Tablets production. Key violations included significant inaccuracies in batch production and inspection records. Records for pre-processing and extraction showed discrepancies in quantities and operational parameters, and an employee was recorded performing sterilization after their reported departure. Furthermore, batch inspection records for Panax notoginseng contained falsified microscopic identification spectra. Data reliability in the QC laboratory was severely compromised. High-performance liquid chromatography (HPLC) systems exhibited hundreds of system time modifications. Electronic chromatograms and audit trail data were deleted, and evidence suggested selective use of chromatograms, with unqualified results being concealed. Additionally, substantial inconsistencies were found in the purchase records for Salvia miltiorrhiza and Panax notoginseng across inventory, supply, and financial documentation. These discrepancies indicate a lack of robust control over raw material procurement. These findings represent serious violations of the "Good Manufacturing Practice for Pharmaceuticals" (2010 Revision). Consequently, the Guangxi Zhuang Autonomous Region Food and Drug Administration has been directed to revoke the company's "Drug GMP Certificate" and pursue legal investigation and punishment.

Company: https://www.globalkeysolutions.net/companies/guangxi-xinlong-pharmaceutical-co-ltd/7971998b-07b1-43d7-ab1e-bbd3d3050c07/