# China NMPA Inspection - Xi'an Zili Traditional Chinese Medicine Group Co., Ltd. - July 12, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/xian-zili-traditional-chinese-medicine-group-co-ltd/4007f564-183a-4a91-9d67-558f3aee86bf
Source feed: China

> China NMPA unannounced inspection for Xi'an Zili Traditional Chinese Medicine Group Co., Ltd. published July 12, 2018. An unannounced inspection by the State Food and Drug Administration's Verification Center, published on July 11, 2018, identified significant deficien

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## Details

- Record Type: CHINA_INSPECTION
- Title: Report on Follow-up Inspection of Xi'an Zili Traditional Chinese Medicine Group Co., Ltd.
- Company Name: Xi'an Zili Traditional Chinese Medicine Group Co., Ltd.
- Publication Date: 2018-07-12
- Product Type: Drugs
- Summary: An unannounced inspection by the State Food and Drug Administration's Verification Center, published on July 11, 2018, identified significant deficiencies at Xi'an Zili Traditional Chinese Medicine Group Co., Ltd. The inspection revealed that the company failed to produce its Cizhu Pill according to the registered process, specifically regarding cinnabar pulverization, and did not assess the impact of these changes on product quality. Furthermore, the company demonstrated insufficient risk assessment and control measures for cross-contamination, particularly in areas and equipment shared between ordinary products and those containing toxic medicinal materials, such as a micro-pulverizer used for both Xiaojin Pill and Cizhu Pill, and inadequate pressure differentials in toxic material processing areas. Critical failures in quality control and assurance were also observed, including approving an intermediate product (Magnetic Cinnabar Pill) that did not meet internal standards, errors in analytical records, improper analytical procedures, and a systemic failure to identify and investigate significant deviations. These findings indicated non-compliance with the *Good Manufacturing Practice for Pharmaceuticals (2010 Revision)* across multiple products. Consequently, the Shaanxi Provincial Food and Drug Administration was directed to revoke the company's relevant GMP certificates and initiate legal proceedings for the identified illegal and irregular activities.

Company: https://www.globalkeysolutions.net/companies/xian-zili-traditional-chinese-medicine-group-co-ltd/ad37b57f-97ba-425b-b3ac-9fd3a4834473