# China NMPA Inspection - Wanhua Puman Biotechnology Co., Ltd. - November 02, 2016

Source: https://www.globalkeysolutions.net/records/china_inspection/wanhua-puman-biotechnology-co-ltd/d4f223fd-27f4-467f-ba12-71203baf7389/
Source feed: China

> China NMPA unannounced inspection for Wanhua Puman Biotechnology Co., Ltd. published November 02, 2016. This document details an unannounced inspection conducted on Wanhua Puman Biotechnology Co., Ltd., with the report officially published on November 2,

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## Details

- Record Type: CHINA_INSPECTION
- Title: Flight inspection of Wanhua Puman Biotechnology Co., Ltd.
- Company Name: Wanhua Puman Biotechnology Co., Ltd.
- Publication Date: 2016-11-02
- Product Type: Device
- Summary: This document details an unannounced inspection conducted on Wanhua Puman Biotechnology Co., Ltd., with the report officially published on November 2, 2016. The inspection revealed that the company's operations and quality management system were in significant non-compliance with the relevant requirements of the Good Manufacturing Practice for Medical Devices (GMP). The primary issues identified centered on deficiencies within its overarching quality management framework, indicating a failure to consistently meet the stringent standards necessary for the manufacture of medical devices. The regulatory framework underpinning this inspection is the Good Manufacturing Practice for Medical Devices, which sets out essential guidelines for ensuring the quality and safety of such products. Consequently, the Beijing Municipal Food and Drug Administration took action, formally ordering Wanhua Puman Biotechnology Co., Ltd. to address and rectify all identified deficiencies. The company is required to implement comprehensive corrective actions within a specified period to bring its practices into full compliance with GMP standards. This directive emphasizes the regulatory authority's role in enforcing quality assurance and protecting public health by ensuring that medical device manufacturers adhere to established safety and efficacy protocols.

Company: https://www.globalkeysolutions.net/companies/wanhua-puman-biotechnology-co-ltd/05f9d0a1-9f1f-4c0f-a6f1-3513f4f91595/