# China NMPA Inspection - Jiangxi Guoyao Co., Ltd. - May 12, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/jiangxi-guoyao-co-ltd/1cf74700-d9b4-40c6-adac-e6d7af38e73b/
Source feed: China

> China NMPA unannounced inspection for Jiangxi Guoyao Co., Ltd. published May 12, 2018. An unannounced inspection of Jiangxi Guoyao Co., Ltd. was conducted by the State Food and Drug Administration and Jiangxi Provincial Food and Drug Adm

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Jiangxi Guoyao Co., Ltd.
- Company Name: Jiangxi Guoyao Co., Ltd.
- Publication Date: 2018-05-12
- Product Type: Drugs
- Summary: An unannounced inspection of Jiangxi Guoyao Co., Ltd. was conducted by the State Food and Drug Administration and Jiangxi Provincial Food and Drug Administration from April 12 to April 15, 2018. Triggered by a complaint, the inspection focused on the company's handling of lincomycin hydrochloride raw materials. Investigations revealed significant deficiencies, specifically that the company primarily purchased and resold lincomycin hydrochloride raw materials with chaotic management practices. The flow of these materials, acquired in substantial quantities between 2016 and 2018, could not be verified or traced. Although the company claimed overseas sales, its warehousing, shipping records, and export documentation did not comply with pharmaceutical Good Manufacturing Practice (GMP) standards. Furthermore, relevant export procedures and certificates were absent, rendering the material's origin and destination untraceable. These actions violated the *Good Manufacturing Practice for Pharmaceuticals* (2010 Revision). As a result, the Jiangxi Provincial Food and Drug Administration ordered the suspension of the company's production and sale of lincomycin hydrochloride active pharmaceutical ingredient (API). The National Medical Products Administration subsequently requested the revocation of the company's GMP certificate for this API and initiated an investigation into potential illegal activities.

Company: https://www.globalkeysolutions.net/companies/jiangxi-guoyao-co-ltd/0e942eaf-c485-45c8-96e1-781141d6bcd4/