# China NMPA Inspection - Hunan Xianquan Natural Biotechnology Co., Ltd. - June 14, 2019

Source: https://www.globalkeysolutions.net/records/china_inspection/hunan-xianquan-natural-biotechnology-co-ltd/9f309cc0-24a2-47ed-9e6c-acccdb82221b/
Source feed: China

> China NMPA unannounced inspection for Hunan Xianquan Natural Biotechnology Co., Ltd. published June 14, 2019. An unannounced inspection of Hunan Xianquan Natural Biotechnology Co., Ltd. was conducted on May 29, 2019, based on the "Cosmetics Hygiene Supervision

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of unannounced inspection of Hunan Xianquan Natural Biotechnology Co., Ltd. (2019002)
- Company Name: Hunan Xianquan Natural Biotechnology Co., Ltd.
- Publication Date: 2019-06-14
- Product Type: Cosmetics
- Summary: An unannounced inspection of Hunan Xianquan Natural Biotechnology Co., Ltd. was conducted on May 29, 2019, based on the "Cosmetics Hygiene Supervision Regulations" and related guidelines. The inspection uncovered multiple deficiencies impacting quality management and operational compliance. Key issues included incomplete personnel files, lack of an official appointment document for the Production Manager, and a failure to appoint a new inspector after a previous one's departure, leading to a gap in cosmetic inspections. Additionally, the company did not conduct training according to its plan, and the Production Manager was unfamiliar with relevant cosmetic regulations.

Significant documentation and quality control problems were noted, such as documents lacking proper review and approval, absence of original finished product inspection records, and no internal audit plan or checklist. The production workshop lacked an environmental monitoring plan, and equipment cleaning and disinfection were not performed according to specified procedures, with incomplete status indicators. The raw material warehouse lacked necessary temperature and humidity control measures. Furthermore, inconsistencies were identified between batch production records and process specifications for products like Sapindus mukorossi Softening Body Wash and Conditioning Shampoo, specifically regarding settling times.

These violations contravened the "Cosmetic Production Licensing Work Specifications." As a result, the Hunan Provincial Drug Administration issued a rectification order, requiring the company to address all identified issues within a specified period and submit a comprehensive rectification report upon completion.

Company: https://www.globalkeysolutions.net/companies/hunan-xianquan-natural-biotechnology-co-ltd/35d3e06f-259f-4d04-80e1-d9286e408954/