# China NMPA Inspection - Yunnan Longhai Natural Plant Medicine Co., Ltd. - January 22, 2016

Source: https://www.globalkeysolutions.net/records/china_inspection/yunnan-longhai-natural-plant-medicine-co-ltd/e77f75b6-251a-4fee-836a-4322f01a4fa9/
Source feed: China

> China NMPA unannounced inspection for Yunnan Longhai Natural Plant Medicine Co., Ltd. published January 22, 2016. Yunnan Longhai Natural Plant Pharmaceutical Co., Ltd. was subjected to an unannounced inspection by the State Food and Drug Administration between Oct

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## Details

- Record Type: CHINA_INSPECTION
- Title: Follow-up Inspection Report on Yunnan Longhai Natural Plant Medicine Co., Ltd.
- Company Name: Yunnan Longhai Natural Plant Medicine Co., Ltd.
- Publication Date: 2016-01-22
- Product Type: Drugs
- Summary: Yunnan Longhai Natural Plant Pharmaceutical Co., Ltd. was subjected to an unannounced inspection by the State Food and Drug Administration between October 20-22, 2015. The inspection revealed severe violations of the Drug Administration Law and Good Manufacturing Practices (GMP) regulations.

Key issues included the illegal production and sale of Fanteng Hemorrhoid Injection without the required GMP certification, a fact the company deliberately concealed. Furthermore, the company was suspected of manufacturing Fantengzhi Injection by significantly deviating from its registered process, including using unapproved raw materials and an unvalidated production method, without confirming equipment suitability. 

Additional problems involved improper storage of both commercial and trial-produced injections, lacking proper labeling and records. Deficiencies were also noted in the water for injection distribution system's temperature monitoring capabilities. The company exhibited inadequate employee training, insufficient evaluation of training effectiveness, inexperienced management, and weak practical skills among operational staff, pointing to systemic failures in quality management.

In response to these serious findings, regulatory measures included the immediate revocation of the company's GMP certificate, an order to cease all production, and a mandate to investigate the illegal manufacturing activities. The company's subsequent application for GMP certification was also denied due to the extensive quality management deficiencies.

Company: https://www.globalkeysolutions.net/companies/yunnan-longhai-natural-plant-medicine-co-ltd/e4fe9c2d-e3ac-4167-bc39-cdf482652246/