# China NMPA Inspection - Jilin Xinhui Pharmaceutical Co., Ltd. - August 07, 2017

Source: https://www.globalkeysolutions.net/records/china_inspection/jilin-xinhui-pharmaceutical-co-ltd/b4787f9a-85a1-4bd3-845b-3923d22250fa/
Source feed: China

> China NMPA unannounced inspection for Jilin Xinhui Pharmaceutical Co., Ltd. published August 07, 2017. Jilin Xinhui Pharmaceutical Co., Ltd. was subjected to an unannounced inspection by the State Food and Drug Administration and the Jilin Provincial Fo

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Jilin Xinhui Pharmaceutical Co., Ltd.
- Company Name: Jilin Xinhui Pharmaceutical Co., Ltd.
- Publication Date: 2017-08-07
- Product Type: Drugs
- Summary: Jilin Xinhui Pharmaceutical Co., Ltd. was subjected to an unannounced inspection by the State Food and Drug Administration and the Jilin Provincial Food and Drug Administration from June 8-10, 2017, triggered by concerns over price-cost discrepancies. The inspection revealed significant violations concerning the production of Huoxiang Zhengqi Water. A primary issue identified was a substantial disparity between the quantities of raw materials, specifically licorice extract and patchouli oil, purchased according to financial invoices, and the amounts legally required for the company's reported production volume of over 127 million vials. The company's financial records indicated purchases far below the necessary ingredient dosages for the stated output. Furthermore, considerable discrepancies were found between financial invoice purchase quantities and the company's internal "Material Classification Ledger" for these extracts, indicating a deficit of over 10,000 kg for licorice extract and hundreds of kilograms for patchouli oil. Additionally, the company's ethanol purchases were severely inadequate to support its declared production. Despite producing 37 batches of percolation products that require substantial ethanol, purchase records only supported enough for 18 batches, highlighting a critical raw material shortage. These findings represent violations of the "Drug Administration Law of the People's Republic of China" and related Good Manufacturing Practice (GMP) regulations. As a result, the State Food and Drug Administration ordered the revocation of the company's relevant GMP certificates, a comprehensive recall of all sold Huoxiang Zhengqi Water products, and the commencement of an investigation into the company's illegal actions.

Company: https://www.globalkeysolutions.net/companies/jilin-xinhui-pharmaceutical-co-ltd/0e864bd1-b082-4645-972a-2a593a5c9958/