# China NMPA Inspection - Wuhan Bodakang Laser Electronic Equipment Co., Ltd. - September 29, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/wuhan-bodakang-laser-electronic-equipment-co-ltd/fd55918a-0cbd-4024-9866-07f5238d5792/
Source feed: China

> China NMPA unannounced inspection for Wuhan Bodakang Laser Electronic Equipment Co., Ltd. published September 29, 2018. Wuhan Bodakang Laser Electronic Equipment Co., Ltd. underwent an unannounced compliance inspection on September 4, 2018, focusing on its Pulsed Nd:YAG

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of unannounced inspection of Wuhan Bodakang Laser Electronic Equipment Co., Ltd.
- Company Name: Wuhan Bodakang Laser Electronic Equipment Co., Ltd.
- Publication Date: 2018-09-29
- Product Type: Device
- Summary: Wuhan Bodakang Laser Electronic Equipment Co., Ltd. underwent an unannounced compliance inspection on September 4, 2018, focusing on its Pulsed Nd:YAG Laser Lacrimal Duct Treatment Machine. The inspection was conducted under the framework of Good Manufacturing Practice for Medical Devices.
The primary finding was that the company was in a state of production stoppage. Inspectors observed all equipment in the production area was shut down, and no staff or machinery were operating. The raw material inventory contained only a small number of components, and the finished product warehouse was empty. This status aligned with a report the company had submitted on January 29, 2018, to the local regulatory authority, formally requesting a cessation of production for its laser treatment machine.
While no active violations related to ongoing production quality were identified due to the production halt, the inspection confirmed the company's inactive status. As a result, specific handling measures were mandated: Wuhan Bodakang Laser Electronic Equipment Co., Ltd. is required to submit a comprehensive written report to the Hubei Provincial Food and Drug Administration before any resumption of manufacturing activities. Production can only recommence after regulatory verification confirms full compliance with all applicable requirements, ensuring product quality and safety standards are met.

Company: https://www.globalkeysolutions.net/companies/wuhan-bodakang-laser-electronic-equipment-co-ltd/c3461a89-843b-4bb5-8e7b-5ffd2b22a239/