# FDA 483 - Hangzhou AGS Meditech Co., Ltd. - May 02, 2019

Source: https://www.globalkeysolutions.net/records/483/hangzhou-ags-meditech-co-ltd/a3a29e2f-f84d-4dd7-9c0f-046cef1483b6

> FDA 483 for Hangzhou AGS Meditech Co., Ltd. on May 02, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hangzhou AGS Meditech Co., Ltd.
- Inspection Date: 2019-05-02
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Hangzhou AGS MedTech Co. Ltd. in Hangzhou, China, revealed significant deficiencies in the firm's quality system. Observations included inadequate procedures for the rework of non-conforming products and a failure to adequately establish CAPA procedures, resulting in continued product complaints without verified corrective actions.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/stephen-d-eich/a932e816-cbe3-4f1c-84e7-8a81cc8b529e)

Company: https://www.globalkeysolutions.net/companies/hangzhou-ags-meditech-co-ltd/a3e3b5bc-6e88-4591-b754-7aa5370e8ce6

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