# China NMPA Inspection - Hainan Yier Pharmaceutical Co., Ltd. - January 12, 2016

Source: https://www.globalkeysolutions.net/records/china_inspection/hainan-yier-pharmaceutical-co-ltd/389b378a-592d-4d28-93c6-31b9af1d4a75/
Source feed: China

> China NMPA unannounced inspection for Hainan Yier Pharmaceutical Co., Ltd. published January 12, 2016. An unannounced inspection of Hainan Yier Pharmaceutical Co., Ltd. by the State Food and Drug Administration and Hainan Provincial Food and Drug Admini

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## Details

- Record Type: CHINA_INSPECTION
- Title: Inspection of Hainan Yier Pharmaceutical Co., Ltd.
- Company Name: Hainan Yier Pharmaceutical Co., Ltd.
- Publication Date: 2016-01-12
- Product Type: Drugs
- Summary: An unannounced inspection of Hainan Yier Pharmaceutical Co., Ltd. by the State Food and Drug Administration and Hainan Provincial Food and Drug Administration occurred from December 24-26, 2015. The inspection uncovered serious violations related to product quality and data integrity. Key issues included significant quality concerns with flupentixol hydrochloride raw material, where on-site testing revealed discrepancies in dissolution and active ingredient content across multiple batches. One problematic batch was confirmed to have been used in finished product manufacturing. Furthermore, the company engaged in systematic data manipulation within its quality control processes, including altering system times on HPLC equipment to falsify test results for raw materials and finished products, and selectively omitting failing test data while using substandard materials in production. Most critically, the company attempted to deceive inspectors by unauthorized replacement of raw material samples initially taken from the warehouse. These actions violated China's "Drug Administration Law" and Good Manufacturing Practice (GMP) regulations. As a result, the regulatory body ordered the immediate revocation of Hainan Yier's GMP certificate and a halt to production. The company is required to investigate the production and sales of flupentixol hydrochloride and flupentixol melitracen tablets, assess all related quality and safety hazards, implement risk control measures such as product recalls, and face further investigation.

Company: https://www.globalkeysolutions.net/companies/hainan-yier-pharmaceutical-co-ltd/3997e4bf-049c-4b7f-9977-2b1ded80cd1a/