# FDA 483 - Tianjin Medis Medical Device Co., LTD. - Unknown Date

Source: https://www.keypedia.com/records/483/tianjin-medis-medical-device-co-ltd/06952832-9faa-4dc5-8693-e9db43bf8b49

> FDA 483 for Tianjin Medis Medical Device Co., LTD. on Unknown Date. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Tianjin Medis Medical Device Co., LTD.
- Product Type: device
- Office Name: International Compliance Team
- Summary: An FDA inspection of Tianjin Medis Medical Device Co., Ltd. in Tianjin, China, revealed two significant observations. The firm failed to adequately document effectiveness checks for several Corrective and Preventive Actions (CAPAs). Additionally, the Design History File for their AccuCuff device lacked essential documentation regarding labels, labeling, and product testing for devices marketed in the United States.

## Related Officers

- [Melanie W. Ashinery](https://www.keypedia.com/people/melanie-w-ashinery/085cb59e-fc26-425e-bf59-d8ce0db7d210)

Company: https://www.keypedia.com/companies/tianjin-medis-medical-device-co-ltd/d68ccebd-5856-4ebb-ad1a-4d523653c139

Office: https://www.keypedia.com/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321