# China NMPA Inspection - Guizhou Shouxian Pharmaceutical Co., Ltd. - April 18, 2016

Source: https://www.globalkeysolutions.net/records/china_inspection/guizhou-shouxian-pharmaceutical-co-ltd/c72b394e-6e89-42a0-ac30-5ab5abcc1025/
Source feed: China

> China NMPA unannounced inspection for Guizhou Shouxian Pharmaceutical Co., Ltd. published April 18, 2016. An unannounced inspection of Guizhou Shouxian Pharmaceutical Co., Ltd. was conducted by the State Food and Drug Administration and Guizhou Provincial 

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Guizhou Shouxian Pharmaceutical Co., Ltd.
- Company Name: Guizhou Shouxian Pharmaceutical Co., Ltd.
- Publication Date: 2016-04-18
- Product Type: Drugs
- Summary: An unannounced inspection of Guizhou Shouxian Pharmaceutical Co., Ltd. was conducted by the State Food and Drug Administration and Guizhou Provincial Food and Drug Administration from March 2-4, 2016. The inspection revealed multiple severe violations of pharmaceutical production regulations. The company illegally continued to produce nine batches of Xiangyu Weishu Compound Preparation after its GMP certificate expired on June 9, 2015. Further issues included the alteration of product batch numbers by repackaging returned goods and re-labeling them for sale. Extensive record falsification was evident, with forged operator signatures in production records, false claims of complete testing for raw materials despite lacking necessary equipment and reference substances, and chronological inconsistencies in review dates. Significant discrepancies between purchased raw materials and those needed for production suggested shoddy workmanship. Material management was severely deficient, characterized by damaged packaging, scattered and unlabeled raw materials in warehouses, and major inconsistencies between inventory records and physical counts for packaging materials. As a result, regulatory authorities ordered the company to seal its entire inventory, recall all distributed products, and initiated a full investigation into these serious illegal production activities, underscoring a fundamental disregard for established pharmaceutical quality and safety standards.

Company: https://www.globalkeysolutions.net/companies/guizhou-shouxian-pharmaceutical-co-ltd/9fb3f927-2417-4b07-b4e4-55a250657066/