# China NMPA Inspection - Guilin Zhongzu Chinese Medicine Co., Ltd. - July 09, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/guilin-zhongzu-chinese-medicine-co-ltd/384bf3e6-7cbe-4e80-abc2-bbe2611db424/
Source feed: China

> China NMPA unannounced inspection for Guilin Zhongzu Chinese Medicine Co., Ltd. published July 09, 2018. An unannounced inspection of Guilin Zhongzu Chinese Medicine Co., Ltd. in 2018, conducted by the State Food and Drug Administration's Verification Cen

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## Details

- Record Type: CHINA_INSPECTION
- Title: Follow-up Inspection Report on Guilin Zhongzu Chinese Medicine Co., Ltd.
- Company Name: Guilin Zhongzu Chinese Medicine Co., Ltd.
- Publication Date: 2018-07-09
- Product Type: Drugs
- Summary: An unannounced inspection of Guilin Zhongzu Chinese Medicine Co., Ltd. in 2018, conducted by the State Food and Drug Administration's Verification Center, uncovered serious non-compliance with pharmaceutical manufacturing standards. The inspection focused on products like Ginseng, Astragalus, and Schisandra Tablets, and syrups.Major violations included the fabrication of inspection reports for packaging materials to deceive inspectors. The company also demonstrated severely inadequate document management, failing to provide crucial batch production, inspection, and release records for finished and intermediate products. Production issues involved mismatched extraction equipment with batch sizes and unreasonable process validation that could not assure intermediate product quality.Material management was chaotic, characterized by a lack of proper ledgers for non-conforming materials, inconsistencies in inventory records for packaging, and storage environments (cool storage) that failed to meet required temperature standards and lacked proper monitoring.Furthermore, the company's Quality Control and Quality Assurance capabilities were deemed insufficient. This included an ineffective deviation management system, improper laboratory sample retention and microbial strain management, and non-standardized data management practices. Issues comprised unclear personnel responsibilities, lack of training, absence of data backup procedures, and critical equipment like the atomic absorption spectrometer lacking audit trail functionality and password control. Manual data alterations on the high-performance liquid chromatograph were performed without proper recording or supervisor approval.Consequently, the company's production quality management for its syrups was found to be non-compliant with the *Good Manufacturing Practice for Pharmaceuticals (2010 Revision)*. The Guangxi Zhuang Autonomous Region Food and Drug Administration was instructed to revoke Guilin Zhongzu Chinese Medicine Co., Ltd.'s GMP certificates and initiate legal proceedings for its illicit activities.

Company: https://www.globalkeysolutions.net/companies/guilin-zhongzu-chinese-medicine-co-ltd/0536c63f-b7d9-43a2-9646-7cac6e1f4828/