# China NMPA Inspection - Jiangsu Pingguang Xinyi (Jiaozuo) Traditional Chinese Medicine Co., Ltd. - May 02, 2017

Source: https://www.globalkeysolutions.net/records/china_inspection/jiangsu-pingguang-xinyi-jiaozuo-traditional-chinese-medicine-co-ltd/854bdcdc-f2f0-4f75-9119-fa3dfec4a739/
Source feed: China

> China NMPA unannounced inspection for Jiangsu Pingguang Xinyi (Jiaozuo) Traditional Chinese Medicine Co., Ltd. published May 02, 2017. An unannounced inspection of Jiangsu Pingguang Xinyi (Jiaozuo) Traditional Chinese Medicine Co., Ltd. was conducted by the State Food and Drug Adminis

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Jiangsu Pingguang Xinyi (Jiaozuo) Traditional Chinese Medicine Co., Ltd.
- Company Name: Jiangsu Pingguang Xinyi (Jiaozuo) Traditional Chinese Medicine Co., Ltd.
- Publication Date: 2017-05-02
- Product Type: Drugs
- Summary: An unannounced inspection of Jiangsu Pingguang Xinyi (Jiaozuo) Traditional Chinese Medicine Co., Ltd. was conducted by the State Food and Drug Administration and Henan Provincial Food and Drug Administration from March 3-5, 2017. The inspection revealed significant violations of Good Manufacturing Practice (GMP) requirements and the "Drug Administration Law of the People's Republic of China". Key issues included a systemic failure to implement GMP across material management, quality control, and quality assurance. The quality management manager did not effectively oversee material review and release. Specific deficiencies in pre-processing involved an unsuitable herb-cutting machine for Platycodon grandiflorus and a complete absence of Standard Operating Procedures or equipment usage logs. Material management was severely disorganized, with instances of rotting ginger, unlabeled intermediate products leading to potential confusion, and inadequate dosage control for multi-batch production. Furthermore, records for Huoxiang Zhengqi Pills contained inaccuracies regarding raw material processing and preparation methods, and the QC laboratory used an expired reference standard for testing. As a result, the company's GMP certificates have been revoked. The Henan Provincial Food and Drug Administration has been instructed to supervise the recall of affected products and to investigate and prosecute the company for suspected illegal production activities.

Company: https://www.globalkeysolutions.net/companies/jiangsu-pingguang-xinyi-jiaozuo-traditional-chinese-medicine-co-ltd/9ae9fd66-b007-454e-8c27-2d84ac4b5588/