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

Source: https://www.globalkeysolutions.net/records/china_inspection/guangxi-zhuangmei-biotechnology-co-ltd/ebda078e-d584-4713-9ff7-c220ffe1a715/
Source feed: China

> China NMPA unannounced inspection for Guangxi Zhuangmei Biotechnology Co., Ltd. published December 19, 2018. The National Medical Products Administration (NMPA) conducted an unannounced inspection of Guangxi Zhuangmei Biotechnology Co., Ltd., with findings an

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## Details

- Record Type: CHINA_INSPECTION
- Title: Announcement Regarding the Suspension of Production and Rectification of Guangxi Zhuangmei Biotechnology Co., Ltd. (No. 129 of 2018)
- Company Name: Guangxi Zhuangmei Biotechnology Co., Ltd.
- Publication Date: 2018-12-19
- Product Type: Cosmetics
- Summary: The National Medical Products Administration (NMPA) conducted an unannounced inspection of Guangxi Zhuangmei Biotechnology Co., Ltd., with findings announced on December 12, 2018. The inspection revealed serious breaches of the "Cosmetic Production Licensing Work Specifications" and "Cosmetic Safety Technical Specifications (2015 edition)," indicating systemic deficiencies in the company's quality management.

Key violations spanned multiple areas. In Personnel Management, inspection staff demonstrated insufficient competence, using incorrect testing methods, while the production manager lacked required qualifications and experience. Quality Management issues included failures in finished product release, incomplete batch records, absence of non-conforming product handling, and missing inspection documentation. Laboratory instruments lacked usage, maintenance, and calibration records, and no system was in place for managing out-of-specification test results.

Further concerns arose in Plant and Facilities, where no environmental monitoring plan existed, and Equipment Management, marked by a lack of cleaning records for the water treatment system and unlabelled pipelines. Material and Product handling was deficient, with improper storage, blank temperature/humidity logs in warehouses, and the presence of expired raw materials. Finally, Production Management showed a lack of critical records such as pre-filling adjustments and in-process inspections.

Consequently, the NMPA has directed the Guangxi Zhuang Autonomous Region Drug Administration to order Guangxi Zhuangmei Biotechnology Co., Ltd. to immediately suspend all production and sales. The company must address all identified deficiencies and undergo a successful follow-up inspection before it can resume operations, with potential legal action for the observed non-compliances.

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