# China NMPA Inspection - Jilin Huinan Sanhe Pharmaceutical Co., Ltd. - December 28, 2015

Source: https://www.globalkeysolutions.net/records/china_inspection/jilin-huinan-sanhe-pharmaceutical-co-ltd/b3d20b9f-9c2a-4713-a0f1-161f09559eec/
Source feed: China

> China NMPA unannounced inspection for Jilin Huinan Sanhe Pharmaceutical Co., Ltd. published December 28, 2015. Jilin Huinan Sanhe Pharmaceutical Co., Ltd. was subjected to an unannounced inspection by the State Food and Drug Administration and Jilin Provincial 

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## Details

- Record Type: CHINA_INSPECTION
- Title: Inspection of Jilin Huinan Sanhe Pharmaceutical Co., Ltd.
- Company Name: Jilin Huinan Sanhe Pharmaceutical Co., Ltd.
- Publication Date: 2015-12-28
- Product Type: Drugs
- Summary: Jilin Huinan Sanhe Pharmaceutical Co., Ltd. was subjected to an unannounced inspection by the State Food and Drug Administration and Jilin Provincial Food and Drug Administration from September 24-26, 2015. The inspection revealed severe breaches of the "Drug Administration Law" and Good Manufacturing Practice (GMP) regulations.Key violations included significant product quality and data integrity issues. Samples of refined coronary heart disease tablets contained unexplained plant tissue, suggesting direct use of raw medicinal powder. Inspection records were suspected of being falsified, with liquid chromatography chromatograms showing suspicious consistency across multiple batches, indicative of data manipulation. The company also lacked complete production and material requisition records for a specific batch (20150901), and its instrument usage logs appeared falsified.Further issues involved substantial discrepancies between ethanol purchase records and actual usage, with internal statistics conflicting with financial data. Additionally, the company purchased materials from an unaudited supplier, which was not on their approved list, and lacked clear material details in financial vouchers.As a result of these serious deficiencies, regulatory authorities mandated stringent actions. Jilin Huinan Sanhe Pharmaceutical Co., Ltd. has been ordered to have its GMP certificate revoked, cease all production activities, and recall all relevant products. A thorough investigation and punishment for all identified illegal and irregular activities are also required to address these critical compliance failures.

Company: https://www.globalkeysolutions.net/companies/jilin-huinan-sanhe-pharmaceutical-co-ltd/837d3189-647d-4100-b385-b2e7095e01b0/