# FDA 483 - Amtai Medical Equipment, INC - February 28, 2022

Source: https://www.keypedia.com/records/483/amtai-medical-equipment-inc/de4d9cc8-c875-450c-a70c-4986e59366f7

> FDA 483 for Amtai Medical Equipment, INC on February 28, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Amtai Medical Equipment, INC
- Inspection Date: 2022-02-28
- Product Type: device
- Office Name: Atlanta District Office
- Summary: Amtai Medical Equipment, INC, a medical device manufacturer in Raleigh, NC, was inspected by the FDA from February 22-28, 2022. The inspection revealed significant deficiencies in their quality system, including inadequate procedures for environmental control, equipment maintenance, labeling activities, and document control. These observations indicate a lack of established and adequately implemented quality system processes.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/inga-m-warr/f27805b8-c2ba-4af5-bf5e-ff2e2f511ec1)

Company: https://www.keypedia.com/companies/amtai-medical-equipment-inc/ea1267b1-0449-4ef0-838c-e4b26c64acec

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7