# China NMPA Inspection - Shanghai Debang Deli Laser Technology Co., Ltd. - August 08, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/shanghai-debang-deli-laser-technology-co-ltd/0bb89068-229f-4cb0-970c-2587cd82f304/
Source feed: China

> China NMPA unannounced inspection for Shanghai Debang Deli Laser Technology Co., Ltd. published August 08, 2018. Shanghai Debang Deli Laser Technology Co., Ltd. underwent an unannounced inspection from July 10 to July 11, 2018, based on the "Good Manufacturing Pr

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of unannounced inspection of Shanghai Debang Deli Laser Technology Co., Ltd.
- Company Name: Shanghai Debang Deli Laser Technology Co., Ltd.
- Publication Date: 2018-08-08
- Product Type: Device
- Summary: Shanghai Debang Deli Laser Technology Co., Ltd. underwent an unannounced inspection from July 10 to July 11, 2018, based on the "Good Manufacturing Practice for Medical Devices." The inspection revealed significant deficiencies across its quality management system, impacting its Semiconductor Laser Therapy Machine and Carbon Dioxide Laser Therapy Machine products. Key violations included a lack of essential wavelength requirements in quality agreements with laser tube suppliers and the absence of specific inspection procedures and equipment for the aiming light wavelength of carbon dioxide laser therapy machines. Furthermore, critical product release authorizations were found to be signed by unqualified personnel, and the actual signatories for product release deviated from documented procedures. The company also failed to conduct necessary review activities following a national sampling non-compliance report. Additional issues encompassed uncalibrated measurement equipment, an outdated quality manual that did not reflect new industry standards (YY/T 0287), and a significant lack of raw data records for laser performance inspections, hindering product traceability. Deficiencies also extended to the absence of established recording requirements for testing equipment usage and a failure to provide documentation for user follow-up visits after product quality issues were identified. In response, the Shanghai Municipal Food and Drug Administration mandated an immediate suspension of production for rectification, risk assessment of products, and recall of any potentially unsafe medical devices, in accordance with the *Regulations on the Supervision and Administration of Medical Devices*. Production can only resume after successful re-inspection and full rectification. The company's actions will be reported to the National Medical Products Administration and publicly disclosed.

Company: https://www.globalkeysolutions.net/companies/shanghai-debang-deli-laser-technology-co-ltd/31c8a4ca-b8cb-458a-b43c-ee6d05c35303/