# FDA 483 - MinXray Inc - August 02, 2022

Source: https://www.globalkeysolutions.net/records/483/minxray-inc/b54df91f-76bc-4cbd-8c48-86a5da85b0ff

> FDA 483 for MinXray Inc on August 02, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: MinXray Inc
- Inspection Date: 2022-08-02
- Product Type: device
- Office Name: Chicago District Office
- Summary: MinXray Inc, an X-Ray Assembler and Importer in Northbrook, IL, was inspected by the FDA, revealing significant deficiencies in its quality system. The firm failed to adequately establish procedures for receiving, reviewing, and evaluating complaints, including proper documentation for Medical Device Report evaluations and consistent complaint investigations. Additionally, procedures for corrective and preventive actions were not adequately implemented, lacking identification of all quality data sources and documentation of effectiveness checks.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/amanda-dinaro/6df79979-ad5c-46f5-8917-197f8a0870e0)

Company: https://www.globalkeysolutions.net/companies/minxray-inc/d52406f8-3ed2-4740-8106-7f0e8e3b7fe4

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