# China NMPA Inspection - Jixi Chenxi Pharmaceutical Co., Ltd. - January 25, 2019

Source: https://www.globalkeysolutions.net/records/china_inspection/jixi-chenxi-pharmaceutical-co-ltd/7ccf115d-e1a5-4ded-b75b-cb6af47e6ac5/
Source feed: China

> China NMPA unannounced inspection for Jixi Chenxi Pharmaceutical Co., Ltd. published January 25, 2019. An unannounced inspection of Jixi Chenxi Pharmaceutical Co., Ltd. was conducted by the Verification Center of the State Food and Drug Administration f

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Jixi Chenxi Pharmaceutical Co., Ltd.
- Company Name: Jixi Chenxi Pharmaceutical Co., Ltd.
- Publication Date: 2019-01-25
- Product Type: Drugs
- Summary: An unannounced inspection of Jixi Chenxi Pharmaceutical Co., Ltd. was conducted by the Verification Center of the State Food and Drug Administration from October 17 to October 19, 2018. The inspection revealed serious non-compliance with the "Good Supply Practice for Pharmaceutical Products." Key violations included the company operating from an unapproved address without completing legal change procedures. Their computer system was inadequate, failing to correlate quality data with business scope, leading to the sale of refrigerated medications to unqualified pharmacies, and lacking complete records for cold chain transportation. The quality management department was deficient, exhibiting incomplete assurance agreements, a lack of essential training for personnel handling specialized pharmaceuticals, and an absent system for evaluating suppliers and purchasers. The company also failed to implement a "two-invoice system" for public hospital transactions. Operational deficiencies included a single individual holding multiple critical roles in the computer system, unauthorized creation of supplier files, incomplete temperature and humidity monitoring records for cold storage, and instances where cold storage temperatures exceeded acceptable limits for sensitive medications. Furthermore, medicine arrangement in the warehouse did not meet regulatory standards. Consequently, the Heilongjiang Provincial Drug Administration revoked Jixi Chenxi Pharmaceutical Co., Ltd.'s "Good Supply Practice for Pharmaceutical Products" certification and initiated an investigation into suspected illegal business practices.

Company: https://www.globalkeysolutions.net/companies/jixi-chenxi-pharmaceutical-co-ltd/1b07bc6d-d5fb-4cdf-b21b-cdf9d24592c0/