# China NMPA Inspection - Jiangsu Hailun Contact Lens Co., Ltd. - April 26, 2017

Source: https://www.globalkeysolutions.net/records/china_inspection/jiangsu-hailun-contact-lens-co-ltd/9c6fbe18-19f3-45d2-bf6e-7eda87df0a00/
Source feed: China

> China NMPA unannounced inspection for Jiangsu Hailun Contact Lens Co., Ltd. published April 26, 2017. An unannounced inspection conducted by the Jiangsu Provincial Food and Drug Administration, operating under the broader regulatory framework of the Na

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## Details

- Record Type: CHINA_INSPECTION
- Title: Inspection of Jiangsu Hailun Contact Lens Co., Ltd.
- Company Name: Jiangsu Hailun Contact Lens Co., Ltd.
- Publication Date: 2017-04-26
- Product Type: devices
- Summary: An unannounced inspection conducted by the Jiangsu Provincial Food and Drug Administration, operating under the broader regulatory framework of the National Medical Products Administration (NMPA), uncovered critical compliance failures at Jiangsu Hailun Contact Lens Co., Ltd. The inspection report, dated April 26, 2017, detailed how the company's manufacturing operations did not adhere to the fundamental requirements of the Good Manufacturing Practice for Medical Devices. These significant lapses pointed to widespread deficiencies within the company's quality management system, essential for ensuring the safety and efficacy of medical devices. Although specific violation details were not provided in the report excerpt, the overarching finding indicated a systemic breakdown in maintaining appropriate production standards. As a direct consequence of these serious regulatory breaches, Jiangsu Hailun Contact Lens Co., Ltd. has received an official order to immediately halt all production activities. The company is further mandated to implement thorough and immediate rectification efforts to bring its operations into full compliance with medical device manufacturing regulations. This robust enforcement action highlights the rigorous oversight exercised by regulatory bodies to protect public health and maintain product integrity in the medical device sector.

Company: https://www.globalkeysolutions.net/companies/jiangsu-hailun-contact-lens-co-ltd/dc6265cd-d201-433a-895e-275875f7a553/