# China NMPA Inspection - Suzhou Contronics Eye Care Products Co., Ltd. - November 23, 2016

Source: https://www.globalkeysolutions.net/records/china_inspection/suzhou-contronics-eye-care-products-co-ltd/d83e0a19-8541-41d2-b9d4-4807cc2879b3/
Source feed: China

> China NMPA unannounced inspection for Suzhou Contronics Eye Care Products Co., Ltd. published November 23, 2016. A regulatory report published on November 23, 2016, by the Jiangsu Provincial Food and Drug Administration detailed the outcomes of an unannounced ins

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## Details

- Record Type: CHINA_INSPECTION
- Title: Flight inspection of Suzhou Contronics Eye Care Products Co., Ltd.
- Company Name: Suzhou Contronics Eye Care Products Co., Ltd.
- Publication Date: 2016-11-23
- Product Type: devices
- Summary: A regulatory report published on November 23, 2016, by the Jiangsu Provincial Food and Drug Administration detailed the outcomes of an unannounced inspection conducted at Suzhou Kangtelans Eye Care Products Co., Ltd. This inspection revealed critical shortcomings in the company's operational processes and its overall quality management system. Specifically, the findings indicated a clear failure by Suzhou Kangtelans to comply with the stringent requirements outlined in the Good Manufacturing Practice for Medical Devices. This non-adherence encompasses multiple aspects of their manufacturing and quality control procedures, signifying substantial deficiencies that could impact product integrity and safety. In response to these significant violations, the Jiangsu Provincial Food and Drug Administration has issued an immediate order to Suzhou Kangtelans Eye Care Products Co., Ltd. The company is mandated to cease all production activities without delay and to implement comprehensive corrective actions. These actions are necessary to rectify the identified issues and ensure full compliance with the regulatory framework governing medical device manufacturing. This decisive regulatory intervention emphasizes the importance of robust quality systems for safeguarding public health.

Company: https://www.globalkeysolutions.net/companies/suzhou-contronics-eye-care-products-co-ltd/9dc5a0d2-2a85-4c6b-8658-984abd4e229f/