# China NMPA Inspection - Hebei Branch of Tianjin Leading Jianlong Pharmaceutical Co., Ltd. - August 24, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/hebei-branch-of-tianjin-leading-jianlong-pharmaceutical-co-ltd/6233fc55-49ae-4a06-9f18-7700b962dd25/
Source feed: China

> China NMPA unannounced inspection for Hebei Branch of Tianjin Leading Jianlong Pharmaceutical Co., Ltd. published August 24, 2018. An unannounced FDA NMPA inspection of Tianjin Leading Jianlong Pharmaceutical Co., Ltd. Hebei Branch was conducted from June 20-23, 2018. The inspecti

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Hebei Branch of Tianjin Leading Jianlong Pharmaceutical Co., Ltd.
- Company Name: Hebei Branch of Tianjin Leading Jianlong Pharmaceutical Co., Ltd.
- Publication Date: 2018-08-24
- Product Type: Drugs
- Summary: An unannounced FDA NMPA inspection of Tianjin Leading Jianlong Pharmaceutical Co., Ltd. Hebei Branch was conducted from June 20-23, 2018. The inspection, part of the annual national pharmaceutical enterprise plan, revealed several serious violations of the "Good Supply Practice for Pharmaceutical Products."Key issues included falsified sales records for clopidogrel bisulfate tablets and rosuvastatin calcium tablets; verifications with purchasing pharmacies confirmed they had not acquired these drugs from the company. Additionally, norepinephrine bitartrate injection purchased by the company was not stored in the warehouse nor recorded in the computer system, indicating poor inventory management. The cool storage area also displayed inaccurate temperature and humidity monitoring, with significant errors compared to calibrated equipment. Furthermore, the company's quality manager was found to be unfamiliar with company operations and quality management duties, suggesting inadequate oversight.As a result, the State Drug Administration has directed the Tianjin Municipal Market and Quality Supervision and Management Commission to revoke the company's "Good Supply Practice for Pharmaceutical Products" certification and initiate an investigation into its suspected illegal and irregular business practices.

Company: https://www.globalkeysolutions.net/companies/hebei-branch-of-tianjin-leading-jianlong-pharmaceutical-co-ltd/7a63fc62-4e4e-460d-8b01-d8bc5eb94184/