# China NMPA Inspection - Jiyuan Jishi Pharmaceutical Co., Ltd., Henan Province - September 30, 2017

Source: https://www.globalkeysolutions.net/records/china_inspection/jiyuan-jishi-pharmaceutical-co-ltd-henan-province/adcac60e-e13d-41fc-a484-175343ff5226/
Source feed: China

> China NMPA unannounced inspection for Jiyuan Jishi Pharmaceutical Co., Ltd., Henan Province published September 30, 2017. An unannounced inspection of Henan Jiyuan Jishi Pharmaceutical Co., Ltd. was conducted from August 24-26, 2017, by the State Food and Drug Administrat

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Jiyuan Jishi Pharmaceutical Co., Ltd., Henan Province
- Company Name: Jiyuan Jishi Pharmaceutical Co., Ltd., Henan Province
- Publication Date: 2017-09-30
- Product Type: Drugs
- Summary: An unannounced inspection of Henan Jiyuan Jishi Pharmaceutical Co., Ltd. was conducted from August 24-26, 2017, by the State Food and Drug Administration. The inspection, prompted by a complaint, revealed significant non-compliance with regulatory standards across the company's manufacturing operations. Key violations included inadequate implementation of responsibilities by production and quality management personnel, such as unauthorized irradiation of intermediate products and failure to investigate out-of-specification results. Quality control was ineffective, with issues like missing original inspection data, suspected falsified microbial test reports, and incomplete stability studies. Material management failures were noted, including untraceable batch numbers and improper storage conditions. The company also failed to follow established production process regulations, improperly managed recycled ethanol without dedicated use or risk assessment, and exhibited severe contamination risks in workshops due to poor hygiene and damaged clean areas. Additionally, equipment usage logs were unavailable. These findings constitute serious violations of the *Good Manufacturing Practice for Pharmaceuticals* (2010 Revision). As a result, the Henan Provincial Food and Drug Administration has been instructed to revoke the company's Pharmaceutical GMP Certificate and pursue legal investigation and penalties.

Company: https://www.globalkeysolutions.net/companies/jiyuan-jishi-pharmaceutical-co-ltd-henan-province/381d10bd-f052-4301-8628-50dcac57400e/