# China NMPA Inspection - Honghu Taining Medical Equipment Co., Ltd. - July 06, 2016

Source: https://www.globalkeysolutions.net/records/china_inspection/honghu-taining-medical-equipment-co-ltd/050030d6-9209-48ec-ae49-4afaebe9ca6d/
Source feed: China

> China NMPA unannounced inspection for Honghu Taining Medical Equipment Co., Ltd. published July 06, 2016. An unannounced inspection by a regulatory body revealed significant non-compliance with the Good Manufacturing Practice (GMP) for medical devices at H

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## Details

- Record Type: CHINA_INSPECTION
- Title: Surprise inspection of Honghu Taining Medical Equipment Co., Ltd.
- Company Name: Honghu Taining Medical Equipment Co., Ltd.
- Publication Date: 2016-07-06
- Product Type: Device
- Summary: An unannounced inspection by a regulatory body revealed significant non-compliance with the Good Manufacturing Practice (GMP) for medical devices at Honghu Taining Medical Device Co., Ltd. The inspection, which likely occurred prior to June 25, 2016, identified critical deficiencies within the company's quality management system. These shortcomings indicated a failure to adhere to established standards for manufacturing medical devices, posing potential risks to product quality and patient safety. As a direct consequence of these findings, Honghu Taining Medical Device Co., Ltd. proactively applied for a production halt on June 25, 2016. To rectify the identified issues and ensure future compliance, the company is mandated to undertake specific corrective actions. Under the regulatory oversight of the Hubei Provincial Food and Drug Administration, the company must submit a comprehensive written report detailing the measures taken to address each deficiency. Production resumption is strictly contingent upon the Hubei Provincial Food and Drug Administration's thorough verification that all regulatory requirements have been fully met and sustained. This rigorous process underscores the importance of upholding stringent quality and safety standards within the medical device industry to protect public health.

Company: https://www.globalkeysolutions.net/companies/honghu-taining-medical-equipment-co-ltd/b6b7e559-b71c-414c-956f-2579cc04e73f/