# China NMPA Inspection - Guangzhou Aixinda Electronics Co., Ltd. - May 28, 2021

Source: https://www.globalkeysolutions.net/records/china_inspection/guangzhou-aixinda-electronics-co-ltd/d4eba3cc-4433-461c-a9bd-fcd4ae4af120/
Source feed: China

> China NMPA unannounced inspection for Guangzhou Aixinda Electronics Co., Ltd. published May 28, 2021. The National Medical Products Administration (NMPA) conducted an unannounced inspection of Guangzhou Aixinda Electronics Co., Ltd. prior to May 27, 20

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## Details

- Record Type: CHINA_INSPECTION
- Title: Announcement No. 34 of 2021 from the National Medical Products Administration regarding the suspension of production and rectification of Guangzhou Aixinda Electronics Co., Ltd.
- Company Name: Guangzhou Aixinda Electronics Co., Ltd.
- Publication Date: 2021-05-28
- Product Type: devices
- Summary: The National Medical Products Administration (NMPA) conducted an unannounced inspection of Guangzhou Aixinda Electronics Co., Ltd. prior to May 27, 2021, uncovering significant deficiencies in its quality management system. The company was found to be non-compliant with the "Good Manufacturing Practice for Medical Devices" and other relevant regulations.

Key violations included organizational ambiguities, with unclear departmental responsibilities for areas like warehouse management. In production, records for medical infrared and electronic thermometers were incomplete or inaccurate, lacking signatures, containing incorrect purchase order numbers, and showing untraceable finished units. Quality control procedures were deficient, featuring undefined criteria for patient leakage current tests and inconsistencies between documented and actual withstand voltage test values. Additionally, sales records were untraceable, as various product batches were not properly registered, and there was no documented process for handling non-conforming intermediate products.

As a result, the NMPA has mandated Guangzhou Aixinda Electronics Co., Ltd. to immediately suspend production for comprehensive rectification. The company must address all identified issues, assess product safety risks, and initiate recalls for any potentially hazardous products under the "Regulations on the Recall of Medical Devices." Resumption of production is contingent upon completing all corrective actions and passing a re-inspection by the Guangdong Provincial Medical Products Administration.

Company: https://www.globalkeysolutions.net/companies/guangzhou-aixinda-electronics-co-ltd/9b763c2d-75a5-49eb-a65f-214cdb675c65/