# China NMPA Inspection - Fujian Meisheng Industrial Group Co., Ltd. - November 20, 2017

Source: https://www.globalkeysolutions.net/records/china_inspection/fujian-meisheng-industrial-group-co-ltd/c38dd34f-07be-4532-ad13-ed5ecbdfedb2/
Source feed: China

> China NMPA unannounced inspection for Fujian Meisheng Industrial Group Co., Ltd. published November 20, 2017. An unannounced inspection was conducted on Fujian Meisheng Industrial Group Co., Ltd. on November 7, 2017, to assess compliance with Good Manufacturin

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of unannounced inspection of Fujian Meisheng Industrial Group Co., Ltd.
- Company Name: Fujian Meisheng Industrial Group Co., Ltd.
- Publication Date: 2017-11-20
- Product Type: Device
- Summary: An unannounced inspection was conducted on Fujian Meisheng Industrial Group Co., Ltd. on November 7, 2017, to assess compliance with Good Manufacturing Practice for Medical Devices. The inspection revealed that the company had suspended all production activities, a status confirmed by on-site verification and a prior explanation submitted by the company in April 2017. A critical finding was that the company's sole Class III medical device product registration certificate, for the Neodymium-doped Yttrium Aluminum Garnet Laser Therapy Machine, had expired on April 6, 2017, and no renewal application had been submitted. Consequently, the company remained in a state of production stoppage. The regulatory framework governing this situation includes the Medical Device Production License and product registration certificates. As a result, the Fujian Provincial Food and Drug Administration was tasked with urging the company to voluntarily apply for the cancellation of its relevant certificates. Furthermore, the administration must closely monitor the company, ensuring that any intent to resume production necessitates reapplication and approval of both product registration certificates and production licenses prior to manufacturing. The authority is also required to oversee the quality and safety of any previously marketed products and mandate that the company uphold its primary responsibility for product quality and safety during the validity period.

Company: https://www.globalkeysolutions.net/companies/fujian-meisheng-industrial-group-co-ltd/32d8afa7-4c31-4db5-aa14-0c2c63a52df6/