# China NMPA Inspection - Hangzhou Dekaili Medical Equipment Co., Ltd. - May 28, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/hangzhou-dekaili-medical-equipment-co-ltd/f168fa7f-b548-4dd8-a092-a683b435a849/
Source feed: China

> China NMPA unannounced inspection for Hangzhou Dekaili Medical Equipment Co., Ltd. published May 28, 2018. An unannounced inspection of Hangzhou Dekaili Medical Equipment Co., Ltd., a manufacturer of Removable Prostheses, was conducted from May 8-9, 2018. T

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Hangzhou Dekaili Medical Equipment Co., Ltd.
- Company Name: Hangzhou Dekaili Medical Equipment Co., Ltd.
- Publication Date: 2018-05-28
- Product Type: Device
- Summary: An unannounced inspection of Hangzhou Dekaili Medical Equipment Co., Ltd., a manufacturer of Removable Prostheses, was conducted from May 8-9, 2018. The inspection, based on the *Good Manufacturing Practice for Medical Devices* and its *Appendix for Customized Dentures*, identified 19 general deficiencies across various aspects of their operations.

Key violations included significant inconsistencies within their quality management system. Documented procedures for product release, disinfection processes, and work instructions often contradicted each other or actual practices. The company failed to provide adequate records for design and development changes, raw material inspection specifications were insufficient, and internal audits did not cover regulatory updates.

Facility and environmental control issues were prominent, with an absence of insect-proof facilities and proper segregation in the finished product warehouse. Critical areas like dust-generating processes were not adequately separated from clean processes. Safety concerns included unsafe storage of gas cylinders, exposed electrical wiring, and a lack of smoke extraction and fire prevention in the foundry.

Process control deficiencies included unvalidated disinfection processes, inconsistent casting temperatures, and unassessed calibration deviations for equipment. Personnel in critical manufacturing areas lacked required health examination certificates. Furthermore, product design sheets were found to be missing essential information like raw material registration numbers, and supplier qualifications for dentist-supplied materials were not provided. Records for disinfection of workpieces and cleaning of workstations were also absent.

Hangzhou Dekaili Medical Equipment Co., Ltd. is required to take primary responsibility for quality and safety, thoroughly analyze the root causes of these deficiencies, assess associated safety risks, and implement necessary corrective and preventive measures to control these risks.

Company: https://www.globalkeysolutions.net/companies/hangzhou-dekaili-medical-equipment-co-ltd/05ae3d6f-dd96-40f7-b78a-f6e3c1da6bd1/