# China NMPA Inspection - Anhui Zhushi Kanghao Traditional Chinese Medicine Pieces Co., Ltd. - June 20, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/anhui-zhushi-kanghao-traditional-chinese-medicine-pieces-co-ltd/4d4f53c2-4ec2-470f-8897-2ae72dfe8e35/
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> China NMPA unannounced inspection for Anhui Zhushi Kanghao Traditional Chinese Medicine Pieces Co., Ltd. published June 20, 2018. Anhui Zhushi Kanghao Traditional Chinese Medicine Pieces Co., Ltd. was subject to an unannounced drug inspection by the Verification Center of the Sta

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## Details

- Record Type: CHINA_INSPECTION
- Title: Report on Follow-up Inspection of Anhui Zhushi Kanghao Traditional Chinese Medicine Pieces Co., Ltd.
- Company Name: Anhui Zhushi Kanghao Traditional Chinese Medicine Pieces Co., Ltd.
- Publication Date: 2018-06-20
- Product Type: Drugs
- Summary: Anhui Zhushi Kanghao Traditional Chinese Medicine Pieces Co., Ltd. was subject to an unannounced drug inspection by the Verification Center of the State Food and Drug Administration, with findings released on June 19, 2018. The inspection identified critical shortcomings in the company's quality control and material management, indicating a failure to comply with the "Good Manufacturing Practice for Pharmaceuticals" (revised in 2010).

Significant violations in the testing laboratory included the omission of required pesticide residue testing for specific varieties. Additionally, the laboratory exhibited inadequate management practices, such as the absence of dust collection during sample crushing and a lack of purchase and usage records for reagents and reference standards. Retained samples were improperly stored, lacking separation, quantity information on labels, and included unlabeled items.

The raw medicinal material warehouse also presented deficiencies, with unlabeled bamboo shavings, inconsistencies between inventory records and actual stock for rehmannia root, and no storage location card for earthworm.

Consequently, the Anhui Provincial Food and Drug Administration was directed to revoke the company's drug GMP certificate and to legally investigate all identified illegal and irregular activities.

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