# China NMPA Inspection - Anhui Zhushi Kanghao Traditional Chinese Medicine Pieces Co., Ltd. - April 17, 2015

Source: https://www.globalkeysolutions.net/records/china_inspection/anhui-zhushi-kanghao-traditional-chinese-medicine-pieces-co-ltd/b3294571-65f5-4503-ae7d-3f325f5692d5/
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> China NMPA unannounced inspection for Anhui Zhushi Kanghao Traditional Chinese Medicine Pieces Co., Ltd. published April 17, 2015. From March 28 to April 1, 2015, Anhui Zhushi Kanghao Traditional Chinese Medicine Pieces Co., Ltd. underwent an unannounced inspection by the State Fo

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## Details

- Record Type: CHINA_INSPECTION
- Title: Inspection of Anhui Zhushi Kanghao Traditional Chinese Medicine Pieces Co., Ltd.
- Company Name: Anhui Zhushi Kanghao Traditional Chinese Medicine Pieces Co., Ltd.
- Publication Date: 2015-04-17
- Product Type: Drugs
- Summary: From March 28 to April 1, 2015, Anhui Zhushi Kanghao Traditional Chinese Medicine Pieces Co., Ltd. underwent an unannounced inspection by the State Food and Drug Administration and Anhui Provincial Food and Drug Administration. The inspection uncovered significant compliance failures, primarily involving the falsification of quality control documentation and a disorganized production quality management system.

Regarding record falsification, the company was found to be generating "Finished Product Inspection Reports" for several traditional Chinese medicine varieties, such as Patchouli and Scutellaria baicalensis, using pre-filled templates. These reports were created without conducting actual tests, as evidenced by the absence of test charts, instrument usage records, and sample retention records.

In terms of quality management, the company maintained incomplete purchase records for most raw medicinal materials, possessing only invoices instead of full records for many varieties. Furthermore, numerous production and inspection records for multiple batches of various products, including Lycium barbarum and Pinellia ternata, were missing. Critically, Anhui Zhushi Kanghao lacked the capability to test for heavy metals and pesticide residues and had not outsourced these essential tests, yet sold products like licorice that required them.

These deficiencies represent serious violations of the Drug Administration Law and applicable Good Manufacturing Practice (GMP) regulations. Consequently, the Anhui Provincial Food and Drug Administration has revoked the company's GMP certificate, mandated an immediate cessation of production, and ordered a recall of all implicated products. Legal investigations have been launched to address the illegal activities, with potential referral to law enforcement if criminal offenses are suspected.

Company: https://www.globalkeysolutions.net/companies/anhui-zhushi-kanghao-traditional-chinese-medicine-pieces-co-ltd/5237e608-eacf-4da1-bbe2-136886309abd/