# FDA 483 - Qlarity Imaging - September 27, 2021

Source: https://www.globalkeysolutions.net/records/483/qlarity-imaging/c56f01fe-c1f2-4ab1-bef1-2ab70d3a5cd0

> FDA 483 for Qlarity Imaging on September 27, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Qlarity Imaging
- Inspection Date: 2021-09-27
- Product Type: device
- Office Name: Chicago District Office
- Summary: An FDA inspection of Qlarity Imaging, a device manufacturer in Chicago, revealed significant deficiencies in the firm's quality system. The inspection found that procedures for Corrective and Preventive Actions (CAPA) were not adequately established, with multiple instances of incomplete documentation for non-conformances, risk assessments, and verification of effectiveness. Additionally, the firm failed to ensure that personnel, specifically the Director of Customer Success, had documented qualifications for critical responsibilities such as CAPA system management, MDR reporting, and product installation.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/qlarity-imaging/481653b0-d39e-4c8f-b515-fa07709c1ccd

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