# China NMPA Inspection - Changsha Weiden Biological Products Co., Ltd. - June 14, 2019

Source: https://www.globalkeysolutions.net/records/china_inspection/changsha-weiden-biological-products-co-ltd/a5c05bb3-72a4-40a6-87d9-ad0eeba5ae59/
Source feed: China

> China NMPA unannounced inspection for Changsha Weiden Biological Products Co., Ltd. published June 14, 2019. An unannounced inspection of Changsha Weideng Biological Products Co., Ltd. was conducted by the Hunan Provincial Drug Administration from May 27 to M

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of unannounced inspection of Changsha Weiden Biological Products Co., Ltd. (2019005)
- Company Name: Changsha Weiden Biological Products Co., Ltd.
- Publication Date: 2019-06-14
- Product Type: Cosmetics
- Summary: An unannounced inspection of Changsha Weideng Biological Products Co., Ltd. was conducted by the Hunan Provincial Drug Administration from May 27 to May 28, 2019. The inspection, based on "Cosmetic Hygiene Supervision Regulations" and "Key Points for Cosmetic Production License Inspection," revealed multiple critical deficiencies in the company’s operations, violating "Cosmetic Production Licensing Work Standards."

Key issues included improper storage of solid raw materials, which lacked airtightness and light protection. The purified water system was found to be severely non-compliant, with no operation, maintenance, cleaning, or disinfection records, an unsealed water storage tank, and a complete absence of quality standards or testing for water used in product preparation.

Furthermore, the company demonstrated poor material traceability, failing to provide purchase invoices for inspected materials, establish inbound/outbound ledgers for raw materials and packaging, or maintain proper purchase and requisition records. Environmental monitoring records for warehouses did not document actions taken when temperature and humidity standards were exceeded. Sterilization records for laboratory glassware and diluents were also missing.

Safety and control issues were noted in the production area, with missing pipeline labels and exposed power cords posing hazards. Deficiencies in document control included a lack of distribution records for quality management system documents and improper identification of valid versus obsolete versions. Finally, the quantity of retained finished product samples was insufficient for testing requirements.

In response, the Hunan Provincial Drug Administration issued a rectification order, compelling Changsha Weideng Biological Products Co., Ltd. to implement corrective measures within a specified timeframe and submit a comprehensive rectification report upon completion.

Company: https://www.globalkeysolutions.net/companies/changsha-weiden-biological-products-co-ltd/cbc15d98-5552-4ddb-b3f5-f3c89a89ef63/