# China NMPA Inspection - Jiangxi Pengshi Guoyaotang Pharmaceutical Co., Ltd. - April 17, 2015

Source: https://www.globalkeysolutions.net/records/china_inspection/jiangxi-pengshi-guoyaotang-pharmaceutical-co-ltd/f960f231-64c7-4d32-83e5-fe5fb9816261/
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> China NMPA unannounced inspection for Jiangxi Pengshi Guoyaotang Pharmaceutical Co., Ltd. published April 17, 2015. From March 25th to 28th, 2015, a surprise inspection by the State Food and Drug Administration and the Jiangxi Provincial Food and Drug Administration

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## Details

- Record Type: CHINA_INSPECTION
- Title: Inspection of Jiangxi Pengshi Guoyaotang Pharmaceutical Co., Ltd.
- Company Name: Jiangxi Pengshi Guoyaotang Pharmaceutical Co., Ltd.
- Publication Date: 2015-04-17
- Product Type: Drugs
- Summary: From March 25th to 28th, 2015, a surprise inspection by the State Food and Drug Administration and the Jiangxi Provincial Food and Drug Administration uncovered serious violations at Jiangxi Pengshi Guoyitang Medicinal Herbs Co., Ltd. Key issues included the falsification of production records, where a single operator was shown processing multiple batches simultaneously, contradicting actual operations. Additionally, inspection records for 2014 products, such as *Danshen* and *Huangqi*, were fabricated, lacking essential tests like content determination and heavy metal analysis required by the *Chinese Pharmacopoeia* (2010 edition), with inspector signatures also appearing to be forged. The company also produced realgar beyond its authorized scope, lacking the necessary license for toxic medicinal slices. These actions significantly violated the "Drug Administration Law" and relevant Good Manufacturing Practice (GMP) regulations. Consequently, the Jiangxi Provincial Food and Drug Administration revoked the company's GMP certificate, ordered an immediate halt to production, mandated a recall of all affected products, and initiated legal proceedings. Cases potentially involving criminal offenses will be transferred to public security organs.

Company: https://www.globalkeysolutions.net/companies/jiangxi-pengshi-guoyaotang-pharmaceutical-co-ltd/782c387c-87f3-40bd-a42d-1870af0bf135/