# China NMPA Inspection - Guilin Gaole Pharmaceutical and Health Products Co., Ltd. - December 19, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/guilin-gaole-pharmaceutical-and-health-products-co-ltd/8c51d916-09e0-44b8-80c6-ae4a4a3aca1f/
Source feed: China

> China NMPA unannounced inspection for Guilin Gaole Pharmaceutical and Health Products Co., Ltd. published December 19, 2018. An unannounced inspection of Guilin Gaole Pharmaceutical & Health Products Co., Ltd. was conducted by regulatory authorities in late 2018, as detailed

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Guilin Gaole Pharmaceutical and Health Products Co., Ltd.
- Company Name: Guilin Gaole Pharmaceutical and Health Products Co., Ltd.
- Publication Date: 2018-12-19
- Product Type: Cosmetics
- Summary: An unannounced inspection of Guilin Gaole Pharmaceutical & Health Products Co., Ltd. was conducted by regulatory authorities in late 2018, as detailed in a report published on December 19, 2018. Based on the "Key Points for Cosmetic Production License Inspection," the inspection uncovered seven deficiencies, including four classified as serious. Significant violations included the quality manager's absence from duty, with release responsibilities improperly assumed by a quality inspector. Crucially, the company lacked a laboratory appropriate for its production scale and products, and failed to develop or implement a workshop environmental monitoring plan. A serious regulatory breach was identified where three distinct cosmetic products (Xiangwuhen Osmanthus Deodorizing Liquid, Aoxianggeli Osmanthus Deodorizing Liquid, and Osmanthus Deodorizing Liquid) were found to share the same approval number. Further issues involved substandard facility conditions, such as rusty mixing room walls and dirty air filters, and inadequate material management, evidenced by uninspected finished products (Batch 20181101) placed in the qualified area. Production management also showed lapses, lacking records for pre-filling machine setup confirmation, first-piece, and patrol inspections. The Guangxi Zhuang Autonomous Region Drug Administration has instructed Guilin Gaole Pharmaceutical & Health Products Co., Ltd. to rectify all identified problems within a specified timeframe. Additionally, the company must submit a report on its corrective actions to the State Drug Administration's Cosmetics Supervision Department within two months. This inspection highlights critical failures in quality control, operational oversight, and compliance with cosmetic production regulations.

Company: https://www.globalkeysolutions.net/companies/guilin-gaole-pharmaceutical-and-health-products-co-ltd/7fcdcc08-5ca3-43f2-b041-0e736e0ce410/