# FDA 483 - Guangzhou Health & Health Medical Equipment Co., Ltd. - March 21, 2019

Source: https://www.globalkeysolutions.net/records/483/guangzhou-health-health-medical-equipment-co-ltd/6bf4da03-5a6b-4f0f-aa6d-bc0e596ff387

> FDA 483 for Guangzhou Health & Health Medical Equipment Co., Ltd. on March 21, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Guangzhou Health & Health Medical Equipment Co., Ltd.
- Inspection Date: 2019-03-21
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Guangzhou Health & Health Medical Equipment Co., Ltd., a medical device manufacturer in Guangzhou, China, was cited for significant deficiencies in its quality system. The inspection revealed inadequate procedures for corrective and preventive actions, a lack of established complaint handling processes, and the absence of written Medical Device Reporting procedures. These issues indicate a systemic failure to manage product quality and safety effectively.

## Related Officers

- [Thai T. Duong](https://www.globalkeysolutions.net/people/thai-t-duong/59737092-2f30-43a7-b23b-36fa7f212c4a)

Company: https://www.globalkeysolutions.net/companies/guangzhou-health-health-medical-equipment-co-ltd/c76a7e57-58c0-4605-9338-3d110f162dc1

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd