# China NMPA Inspection - Yangzhou Twelve Pink Biotechnology Co., Ltd. - October 10, 2017

Source: https://www.globalkeysolutions.net/records/china_inspection/yangzhou-twelve-pink-biotechnology-co-ltd/d3da39e1-7da5-4197-992a-d9712554a279/
Source feed: China

> China NMPA unannounced inspection for Yangzhou Twelve Pink Biotechnology Co., Ltd. published October 10, 2017. An unannounced inspection of Yangzhou Twelve Pink Biotechnology Co., Ltd. was conducted on September 14, 2017, by the National Food and Drug Administr

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## Details

- Record Type: CHINA_INSPECTION
- Title: Supervision and Inspection Report on Yangzhou Twelve Pink Biotechnology Co., Ltd.
- Company Name: Yangzhou Twelve Pink Biotechnology Co., Ltd.
- Publication Date: 2017-10-10
- Product Type: Cosmetics
- Summary: An unannounced inspection of Yangzhou Twelve Pink Biotechnology Co., Ltd. was conducted on September 14, 2017, by the National Food and Drug Administration and Jiangsu Provincial Food and Drug Administration. The inspection, based on the "Key Points for Cosmetic Production License Inspection," revealed significant deficiencies across multiple operational areas.

Key issues included an incomplete quality management system, with document management lacking standardization, such as proper authorization and dates. The production workshop exhibited environmental control failures, specifically the absence of environmental monitoring systems, differential pressure displays for purification units and cleanrooms, and inadequate cleaning protocols for purification systems.

Equipment management was also found wanting; process water units were not standardized, lacking flow direction indicators and proper sampling points. Cleaning and disinfection procedures for production equipment lacked status markings and a complete management system.

Furthermore, material and product storage practices were highly problematic. Raw materials like glycerin were improperly stored outdoors, exposed to sunlight. In-process materials lacked labeling, and all stored items, including raw materials, packaging, and finished products, were not managed in designated areas, lacked location cards, and were placed against walls without adequate pest control or ventilation. Sample retention management was also incomplete, with unsuitable storage conditions.

The company is required to rectify these issues within a specified timeframe, after which the Jiangsu Provincial Food and Drug Administration must report the completion of corrective actions to the State Administration for Market Regulation.

Company: https://www.globalkeysolutions.net/companies/yangzhou-twelve-pink-biotechnology-co-ltd/b97c6598-e4ab-4bd0-a74c-e2e7846c88e8/