# China NMPA Inspection - Shandong Yinhe Biotechnology Co., Ltd. - July 10, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/shandong-yinhe-biotechnology-co-ltd/54639593-bce7-4458-8461-4cfbba512d0c/
Source feed: China

> China NMPA unannounced inspection for Shandong Yinhe Biotechnology Co., Ltd. published July 10, 2018. An unannounced inspection of Shandong Yinhe Biotechnology Co., Ltd., conducted by the National Food and Drug Administration and the Shandong Provincia

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of unannounced inspection of Shandong Yinhe Biotechnology Co., Ltd.
- Company Name: Shandong Yinhe Biotechnology Co., Ltd.
- Publication Date: 2018-07-10
- Product Type: Cosmetics
- Summary: An unannounced inspection of Shandong Yinhe Biotechnology Co., Ltd., conducted by the National Food and Drug Administration and the Shandong Provincial Food and Drug Administration on June 21-22, 2018, uncovered significant regulatory non-compliance. Based on the "Key Points for Cosmetic Production License Inspection" framework, the inspection identified nine deficiencies, comprising four serious and five general issues.

Key serious violations included an expired workshop environmental testing report, critical cross-contamination risks from inadequate separation between raw material and cosmetic production in a shared clean area, severe hygiene issues in the packaging material warehouse (cobwebs, insect carcasses), and a complete absence of operation and maintenance records for the water treatment system.

General defects encompassed the lack of usage records for laboratory instruments, unlabelled disinfectant containers, inadequate temperature and humidity control in the finished product warehouse, and failures in sample retention, including improper storage conditions and insufficient quantities for "Eve's Kiss Hyaluronic Acid Daytime Hydrating Essence."

Consequently, the Shandong Provincial Food and Drug Administration is required to mandate prompt rectification by the company. Upon successful completion of these corrective actions, the provincial authority must report the outcomes to the State Drug Administration.

Company: https://www.globalkeysolutions.net/companies/shandong-yinhe-biotechnology-co-ltd/890527df-377f-4f6d-89a4-61e8c22f16d9/