# China NMPA Inspection - Jiangxi Puzheng Pharmaceutical Co., Ltd. - May 27, 2016

Source: https://www.globalkeysolutions.net/records/china_inspection/jiangxi-puzheng-pharmaceutical-co-ltd/3586886d-0ef8-4597-b28d-910d808b43c0/
Source feed: China

> China NMPA unannounced inspection for Jiangxi Puzheng Pharmaceutical Co., Ltd. published May 27, 2016. An unannounced inspection of Jiangxi Puzheng Pharmaceutical Co., Ltd. was conducted by the State Food and Drug Administration and Jiangxi Provincial F

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Jiangxi Puzheng Pharmaceutical Co., Ltd.
- Company Name: Jiangxi Puzheng Pharmaceutical Co., Ltd.
- Publication Date: 2016-05-27
- Product Type: Drugs
- Summary: An unannounced inspection of Jiangxi Puzheng Pharmaceutical Co., Ltd. was conducted by the State Food and Drug Administration and Jiangxi Provincial Food and Drug Administration from April 27 to May 1, 2016. The inspection uncovered significant issues primarily related to the production of Chuanwang Anti-inflammatory Capsules.

The company was found to have unilaterally reduced the dosage of critical raw materials, Andrographis paniculata and Lycopodium clavatum, using only 70% of the approved amounts between January 2015 and April 2016. To conceal this unauthorized deviation from registered formulations and manufacturing processes, the company systematically falsified production records. Original records reflecting actual raw material usage were destroyed, and fabricated documents were created to indicate compliance, inflating reported material usage by approximately 30%.

These actions constituted serious breaches of the *Drug Administration Law* and relevant Good Manufacturing Practice (GMP) regulations. In response, the State Food and Drug Administration ordered several immediate actions: sealing all existing inventory of Chuanwang Anti-inflammatory Capsules, launching a comprehensive investigation into the product's production and sales, and initiating a full recall of all affected products on the market. Furthermore, the Jiangxi Provincial Food and Drug Administration has already revoked the company's relevant GMP certificates, underscoring the gravity of the non-compliance.

Company: https://www.globalkeysolutions.net/companies/jiangxi-puzheng-pharmaceutical-co-ltd/a6bc3a25-8d62-4585-8f7e-0c18042d4a58/