# FDA 483 - MIE America, Inc. - September 14, 2023

Source: https://www.globalkeysolutions.net/records/483/mie-america-inc/c31428ab-ec26-4d4e-91ec-a5458a8903de

> FDA 483 for MIE America, Inc. on September 14, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: MIE America, Inc.
- Inspection Date: 2023-09-14
- Product Type: device
- Office Name: Chicago District Office
- Summary: MIE America, Inc., an initial importer and servicer of nuclear medicine imaging machines in Elk Grove Village, IL, received a Form FDA 483 with three observations. The inspection revealed significant deficiencies in the firm's quality system, including inadequate corrective and preventive action procedures, a lack of established quality audit procedures, and management's failure to ensure the quality policy is understood and implemented throughout the organization. These issues indicate a systemic breakdown in maintaining a compliant quality system.

## Related Officers

- [Medical Device Specialist](https://www.globalkeysolutions.net/people/jesse-a-vazquez/cac5b170-d0ea-4355-af5d-3d81546ff0fe)

Company: https://www.globalkeysolutions.net/companies/mie-america-inc/a1a7c905-2644-442b-8b33-caddfb71a6ac

Office: https://www.globalkeysolutions.net/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669