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

Source: https://www.globalkeysolutions.net/records/china_inspection/hunan-hongkai-biotechnology-co-ltd/75f1a177-0fbc-4dbb-ad3e-e2dd8f47c0cb/
Source feed: China

> China NMPA unannounced inspection for Hunan Hongkai Biotechnology Co., Ltd. published June 14, 2019. An unannounced inspection of Hunan Hongkai Biotechnology Co., Ltd. was conducted by the Hunan Provincial Drug Administration from May 27 to May 29, 20

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of unannounced inspection of Hunan Hongkai Biotechnology Co., Ltd. (2019004)
- Company Name: Hunan Hongkai Biotechnology Co., Ltd.
- Publication Date: 2019-06-14
- Product Type: Cosmetics
- Summary: An unannounced inspection of Hunan Hongkai Biotechnology Co., Ltd. was conducted by the Hunan Provincial Drug Administration from May 27 to May 29, 2019. The inspection, based on national cosmetic hygiene supervision regulations and production license inspection guidelines, identified multiple deficiencies in the company
s operations.

Key violations included the failure to establish updated enterprise standards for raw materials, semi-finished, and finished products as per the "Cosmetic Safety Technical Specifications" (2015). Furthermore, one product, "Fanmilin Natural Protective Isolation BB Cream," was suspected of making an unsubstantiated "sunscreen" efficacy claim. Significant issues were also noted in quality management, with the quality manager failing to fulfill responsibilities effectively, including improper finished cosmetic release procedures.

Deficiencies in material control and documentation were evident, such as inadequate batch number recording and location cards for packaging materials, and inconsistent batch numbering for finished products, where different production cycles shared the same batch number. Production records lacked crucial details like disinfection methods for inner packaging materials, and the cosmetic sample retention system was not consistently followed, with some samples missing or insufficient in quantity.

Infrastructure concerns included unmarked production water pipes and a design flaw in the clean area, specifically a shared corridor between the material passageway and filling room without a necessary buffer or pass-through window. These issues collectively indicated a failure to comply with "Cosmetic Production Licensing Work Specifications." As a result, the Hunan Provincial Drug Administration issued a rectification order, mandating the company to address all identified deficiencies within a specified timeframe and submit a comprehensive rectification report.

Company: https://www.globalkeysolutions.net/companies/hunan-hongkai-biotechnology-co-ltd/e469bec1-5656-4756-91ca-72615f33761d/