# China NMPA Inspection - Nanjing Yigao Microwave System Engineering Co., Ltd. - October 22, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/nanjing-yigao-microwave-system-engineering-co-ltd/da5469be-b73e-4b2f-a1bf-6ad67e8fb99b/
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> China NMPA unannounced inspection for Nanjing Yigao Microwave System Engineering Co., Ltd. published October 22, 2018. Nanjing Yigao Microwave System Engineering Co., Ltd. underwent an unannounced inspection by the NMPA on September 20-21, 2018, based on the Good Manuf

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of unannounced inspection of Nanjing Yigao Microwave System Engineering Co., Ltd.
- Company Name: Nanjing Yigao Microwave System Engineering Co., Ltd.
- Publication Date: 2018-10-22
- Product Type: Device
- Summary: Nanjing Yigao Microwave System Engineering Co., Ltd. underwent an unannounced inspection by the NMPA on September 20-21, 2018, based on the Good Manufacturing Practice for Medical Devices. The inspection revealed seven significant deficiencies, including two serious and five minor issues, indicating systemic failures in the company's quality management system for its High-Frequency Surgical System.

Key violations included a complete lack of traceability for a specific high-frequency electrosurgical unit due to missing production and inspection records. The company failed to comply with national mandatory standards for factory inspection procedures, evidenced by incorrect parameters used in high-frequency leakage current tests and inaccurate timing during cable withstand voltage and finished product leakage current tests. Furthermore, inadequate weighing equipment led to material damage and unreliable inventory management. Defects in original records were noted, such as unconfirmed alterations to product specifications and missing historical usage records for critical testing equipment. The company also lacked confirmed design change documentation for product modifications and maintained inaccurate supplier information. Critically, after a prior national sampling failure, Nanjing Yigao did not implement effective measures to prevent recurrence across its product lines.

As a result, the Jiangsu Provincial Food and Drug Administration ordered an immediate production suspension for rectification under the "Regulations on the Supervision and Administration of Medical Devices." The company is required to analyze root causes, assess product safety risks, and recall any hazardous products. Production can only resume after all deficiencies are fully rectified and a successful follow-up inspection is completed. The rectification progress will be publicly disclosed.

Company: https://www.globalkeysolutions.net/companies/nanjing-yigao-microwave-system-engineering-co-ltd/02a2cba7-f15c-48b2-8ee0-28e3d33bd79e/