# China NMPA Inspection - Harbin Dingxiang Medical Equipment Co., Ltd. - July 28, 2016

Source: https://www.globalkeysolutions.net/records/china_inspection/harbin-dingxiang-medical-equipment-co-ltd/0ab7d59e-e47a-4301-b6c5-9a7f2dbed3df/
Source feed: China

> China NMPA unannounced inspection for Harbin Dingxiang Medical Equipment Co., Ltd. published July 28, 2016. An unannounced inspection report, published on July 28, 2016, by the National Medical Products Administration (NMPA), detailed significant non-complia

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## Details

- Record Type: CHINA_INSPECTION
- Title: Inspection of Harbin Dingxiang Medical Device Co., Ltd.
- Company Name: Harbin Dingxiang Medical Equipment Co., Ltd.
- Publication Date: 2016-07-28
- Product Type: devices
- Summary: An unannounced inspection report, published on July 28, 2016, by the National Medical Products Administration (NMPA), detailed significant non-compliance issues at Harbin Dingxiang Medical Device Co., Ltd. The inspection revealed that the company's operational practices did not adhere to the relevant requirements of the Good Manufacturing Practice for Medical Devices (GMP). Specifically, the regulatory body identified deficiencies within the company's quality management system. While the provided text indicates that a table of specific non-compliant actions was detailed in the original document, the overarching finding was a failure to meet established manufacturing standards. As a direct consequence of these findings, the Heilongjiang Provincial Food and Drug Administration issued a directive to Harbin Dingxiang Medical Device Co., Ltd. The company has been mandated to address and rectify all identified deficiencies within its quality management system and operational procedures within a specified timeframe. This regulatory action underscores the NMPA's commitment to ensuring product quality and safety within the medical device industry in China, emphasizing the importance of strict adherence to GMP standards to maintain regulatory compliance.

Company: https://www.globalkeysolutions.net/companies/harbin-dingxiang-medical-equipment-co-ltd/ae2bdfbc-b2c4-47c6-87c8-f9f1850e6fc3/