The State Food and Drug Administration issued a notice on the suspension of production and rectification of Guangzhou Aixinda Electronics Co., Ltd.

Recently, the State Food and Drug Administration organized an unannounced inspection of Guangzhou Aixinda Electronics Co.

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Fourth, sales and after-sales

The sales records of enterprises cannot be traced back.

Five, the control of non-conforming products

If the enterprise fails to provide the disposal record of the unqualified intermediate product in the production process, the enterprise that does not comply with the "Specifications" shall mark, record, isolate, and review the unqualified product, and take corresponding measures for the unqualified product based on the review result Claim.

The company's quality management system has serious defects and does not comply with the relevant regulations of the medical device production quality management norms.

The State Drug Administration instructs the Guangdong Provincial Drug Administration to order the company to immediately stop production for rectification in accordance with the law, and severely deal with violations of the "Regulations on the Supervision and Administration of Medical Devices" and related laws and regulations in accordance with the law; instruct the Guangdong Provincial Drug Administration to order the company Evaluate product safety risks, and recall related products in accordance with the "Medical Device Recall Management Measures" if they may cause potential safety hazards.

The enterprise can resume production only after it has completed all project rectifications and passed the re-examination by Guangdong Drug Administration.