# China NMPA Inspection - Lanzhou Xukang Pharmaceutical Co., Ltd. - May 23, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/lanzhou-xukang-pharmaceutical-co-ltd/8e43fa60-d608-4ed2-8551-b9d459bbbb9f/
Source feed: China

> China NMPA unannounced inspection for Lanzhou Xukang Pharmaceutical Co., Ltd. published May 23, 2018. An inspection by the State Food and Drug Administration's Verification Center identified significant non-compliance at Lanzhou Xukang Pharmaceutical C

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## Details

- Record Type: CHINA_INSPECTION
- Title: Report on Follow-up Inspection of Lanzhou Xukang Pharmaceutical Co., Ltd.
- Company Name: Lanzhou Xukang Pharmaceutical Co., Ltd.
- Publication Date: 2018-05-23
- Product Type: Drugs
- Summary: An inspection by the State Food and Drug Administration's Verification Center identified significant non-compliance at Lanzhou Xukang Pharmaceutical Co., Ltd., regarding its traditional Chinese medicine decoction pieces. While specific inspection dates were not provided, the findings were published on May 22, 2018, as part of a planned drug inspection.

The company exhibited critical failures in quality control and manufacturing practices. Key issues included not conducting mandatory quality inspections for numerous batches of raw materials, such as Astragalus membranaceus and Lycium barbarum, which lacked content determination, heavy metal, harmful element, or pesticide residue testing. Other herbs, including Bitter almond and Peony bark, also failed to undergo required quality standard tests.

Furthermore, the inspection highlighted poor warehouse management, with all Chinese medicinal materials stored in identical packaging bags, lacking external labels, and without proper segregation between different batches and varieties, increasing the risk of mix-ups. The company also neglected to perform retrospective quality analyses for previously recalled products, specifically leech and stir-fried immature bitter orange. Lastly, it was determined that the production facility at No. 58, Huishuiwan, Lanzhou City, lacked the necessary equipment for calcination, invalidating its certification for this process.

These violations indicate non-adherence to the *Good Manufacturing Practice for Pharmaceuticals* (2010 Revision). Consequently, the Gansu Provincial Food and Drug Administration has been directed to revoke the company's relevant GMP certificates and initiate legal proceedings for the identified illegal and irregular activities.

Company: https://www.globalkeysolutions.net/companies/lanzhou-xukang-pharmaceutical-co-ltd/78eccb0c-2763-44b3-8438-fa5ef12089ce/