# China NMPA Inspection - Guangxi Zhuangmei Biotechnology Co., Ltd. - December 19, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/guangxi-zhuangmei-biotechnology-co-ltd/8c95fe4a-0655-483c-b78f-e3c5db979071/
Source feed: China

> China NMPA unannounced inspection for Guangxi Zhuangmei Biotechnology Co., Ltd. published December 19, 2018. An unannounced inspection of Guangxi Zhuangmei Biotechnology Co., Ltd., with findings published on December 19, 2018, revealed significant non-complia

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of unannounced inspection of Guangxi Zhuangmei Biotechnology Co., Ltd.
- Company Name: Guangxi Zhuangmei Biotechnology Co., Ltd.
- Publication Date: 2018-12-19
- Product Type: Cosmetics
- Summary: An unannounced inspection of Guangxi Zhuangmei Biotechnology Co., Ltd., with findings published on December 19, 2018, revealed significant non-compliance with cosmetic production licensing requirements, specifically the "Cosmetic Production Licensing Work Specifications" and "Cosmetic Safety Technical Specifications (2015 Edition)". The inspection uncovered 6 serious and 11 general defects across various operational areas.

Key violations included systemic issues in personnel management, such as inadequate competence among inspection and production management staff, and a lack of records for external personnel entering production areas. Quality management failures were widespread, including improper finished product release procedures, incomplete batch production records, absence of non-conforming product handling, missing inspection documentation, and deficient laboratory instrument management, compounded by the lack of a system for managing out-of-specification results.

Serious deficiencies in plant and facilities involved the absence of a workshop environmental monitoring plan and regular monitoring. Equipment management issues included a lack of regular cleaning and disinfection records for the water treatment system, which also displayed severe scaling, along with general deficiencies in equipment use and maintenance records. Material and product management was also substandard, with improper raw material storage, missing temperature and humidity logs for warehouses, and the presence of expired raw materials. Furthermore, production management lacked essential pre-filling adjustment, first-piece inspection, and patrol inspection records.

As a direct consequence of these violations, Guangxi Zhuangmei Biotechnology Co., Ltd. was ordered to immediately suspend all cosmetic production and sales. The company is required to undertake comprehensive rectification of all identified issues. Resumption of production and sales is contingent upon the Guangxi Zhuang Autonomous Region Drug Administration confirming full compliance with cosmetic production licensing requirements, with subsequent notification to the State Drug Administration.

Company: https://www.globalkeysolutions.net/companies/guangxi-zhuangmei-biotechnology-co-ltd/424c3f44-b010-4b0d-9b2c-d5b9694f49ac/