# China NMPA Inspection - Diaoyutai Pharmaceutical Group Jilin Tianqi Pharmaceutical Co., Ltd. - July 12, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/diaoyutai-pharmaceutical-group-jilin-tianqi-pharmaceutical-co-ltd/c1d5ff16-bf78-43ee-b8c5-d8440eb5b147/
Source feed: China

> China NMPA unannounced inspection for Diaoyutai Pharmaceutical Group Jilin Tianqi Pharmaceutical Co., Ltd. published July 12, 2018. An unannounced inspection by the State Food and Drug Administration identified critical compliance failures at Diaoyutai Pharmaceutical Group Jilin Ti

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Follow-up Inspection of Diaoyutai Pharmaceutical Group Jilin Tianqi Pharmaceutical Co., Ltd.
- Company Name: Diaoyutai Pharmaceutical Group Jilin Tianqi Pharmaceutical Co., Ltd.
- Publication Date: 2018-07-12
- Product Type: Drugs
- Summary: An unannounced inspection by the State Food and Drug Administration identified critical compliance failures at Diaoyutai Pharmaceutical Group Jilin Tianqiang Pharmaceutical Co., Ltd., under a drug tracking inspection plan covering activities up to 2018. Significant issues included irregular management of medicinal materials, with a lack of source certificates and legal invoices for ingredients like donkey-hide gelatin and lizards, and discrepancies between financial and purchasing records. Data reliability was severely compromised by missing original inspection records, multiple calculation errors in content determinations (some of which incorrectly validated unqualified materials), and inadequate computer system permissions allowing data manipulation and lack of audit trails. Furthermore, the company exhibited substantial discrepancies between batch production records, material ledgers, and financial inventory data for both finished products and raw materials. Critical process validations for drug products such as Jiegu Xujin Pian and Nvbao Jiaonang were not performed. Lastly, quality control laboratory management was substandard, lacking essential documentation for reference solution preparation and usage. These findings point to systemic weaknesses in quality assurance, data integrity, and production control. The company is required to implement comprehensive corrective actions to ensure compliant material sourcing, robust data management, accurate record-keeping, complete process validation, and enhanced laboratory practices to meet regulatory standards.

Company: https://www.globalkeysolutions.net/companies/diaoyutai-pharmaceutical-group-jilin-tianqi-pharmaceutical-co-ltd/ebc77766-2622-4cb2-9205-c9d5537dbb41/