# China NMPA Inspection - Guangxi Yulin Huaantang Traditional Chinese Medicine Pieces Co., Ltd. - March 27, 2015

Source: https://www.globalkeysolutions.net/records/china_inspection/guangxi-yulin-huaantang-traditional-chinese-medicine-pieces-co-ltd/f7c4c75f-a5db-4f8c-a57b-6e39eb53705f/
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> China NMPA unannounced inspection for Guangxi Yulin Huaantang Traditional Chinese Medicine Pieces Co., Ltd. published March 27, 2015. An unannounced inspection conducted by the State Food and Drug Administration and the Guangxi Zhuang Autonomous Region Food and Drug Administration fr

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## Details

- Record Type: CHINA_INSPECTION
- Title: Inspection of Guangxi Yulin Xiang Sheng Traditional Chinese Medicine Pieces Co., Ltd.
- Company Name: Guangxi Yulin Huaantang Traditional Chinese Medicine Pieces Co., Ltd.
- Publication Date: 2015-03-27
- Product Type: Drugs
- Summary: An unannounced inspection conducted by the State Food and Drug Administration and the Guangxi Zhuang Autonomous Region Food and Drug Administration from March 2nd to 4th, 2015, revealed severe non-compliance at Guangxi Yulin Xiang Sheng Traditional Chinese Medicine Pieces Co., Ltd. The company is suspected of significant violations, including issuing false invoices and colluding to facilitate illegal production and operation by other pharmaceutical entities. Specifically, 704 product batches lacked essential warehousing records, and production or purchase documentation was absent for several key medicinal materials like Smilax glabra and Rehmannia glutinosa.

Furthermore, the inspection exposed highly disorganized quality management practices. Operators did not complete production records, and numerous inspection records, finished product warehousing slips, and raw material inspection requests were forged. Discrepancies were found between production and inventory records for items such as Safflower and Licorice. The company's laboratory was inadequately equipped, lacking a high-performance liquid chromatograph (HPLC) for content determination, and failed to conduct required heavy metal, pesticide residue, and aflatoxin tests for products like licorice and dried tangerine peel in 2013 and 2014.

These actions represent serious violations of the "Drug Administration Law" and relevant Good Manufacturing Practice (GMP) regulations. Consequently, the Guangxi Zhuang Autonomous Region Food and Drug Administration has mandated an immediate cessation of production and sales, alongside a full recall of all Chinese herbal medicine pieces. The regulatory body has also initiated procedures to revoke the company's production license, launched investigations into the identified illegal activities, and will transfer the case to public security authorities if criminal offenses are suspected.

Company: https://www.globalkeysolutions.net/companies/guangxi-yulin-huaantang-traditional-chinese-medicine-pieces-co-ltd/12088ba5-957b-470a-bc17-ee79f5faed41/