# China NMPA Inspection - Chongqing Quanxinxiangsheng Biopharmaceutical Co., Ltd. - December 31, 2015

Source: https://www.globalkeysolutions.net/records/china_inspection/chongqing-quanxinxiangsheng-biopharmaceutical-co-ltd/d473b88c-4c15-4ef4-adc5-d6ea1e672a8e/
Source feed: China

> China NMPA unannounced inspection for Chongqing Quanxinxiangsheng Biopharmaceutical Co., Ltd. published December 31, 2015. An unannounced inspection of Chongqing Quanxin Xiangsheng Biopharmaceutical Co., Ltd. by the State Food and Drug Administration and Chongqing Municipa

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## Details

- Record Type: CHINA_INSPECTION
- Title: Inspection of Chongqing Quanxin Xiangcheng Biopharmaceutical Co., Ltd.
- Company Name: Chongqing Quanxinxiangsheng Biopharmaceutical Co., Ltd.
- Publication Date: 2015-12-31
- Product Type: Drugs
- Summary: An unannounced inspection of Chongqing Quanxin Xiangsheng Biopharmaceutical Co., Ltd. by the State Food and Drug Administration and Chongqing Municipal Food and Drug Administration, conducted from December 26-29, 2015, revealed multiple significant violations of Good Manufacturing Practices (GMP) regulations. Key issues included substantial inaccuracies and discrepancies in production and material records, with documented citric acid usage exceeding purchase quantities and a complete absence of essential finished product documentation, such as sales and inspection ledgers, for several batches. The company also demonstrated inadequate quality control for raw materials like iron filings and steel bars used in ferric ammonium citrate production, lacking comprehensive quality standards and internal controls, particularly for chromium content. These materials were procured from unaudited individual suppliers without proper inspection reports, and on-site testing confirmed elevated chromium levels in both raw materials and finished products. Furthermore, some production areas for ferric ammonium citrate lacked proper GMP management and status indicators, increasing the risk of product quality issues. Lastly, nine batches of finished drug products were discovered stored in unsuitable, non-compliant conditions. Consequently, regulatory authorities have ordered the revocation of the company's GMP certificate, an immediate cessation of production, an investigation into sales, and the recall of all affected products.

Company: https://www.globalkeysolutions.net/companies/chongqing-quanxinxiangsheng-biopharmaceutical-co-ltd/7c9548d3-1959-471b-9ee7-c9f4ce24ddce/