# FDA 483 - IRAY IMAGING LLC - October 24, 2025

Source: https://www.globalkeysolutions.net/records/483/iray-imaging-llc/b19caacf-06bf-49b5-9edc-186c4ce6f888

> FDA 483 for IRAY IMAGING LLC on October 24, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: IRAY IMAGING LLC
- Inspection Date: 2025-10-24
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: IRAY IMAGING LLC, a medical device contract manufacturer in Solon, OH, was inspected by the FDA from October 20-24, 2025. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate procedures for corrective and preventive actions, control of nonconforming product, incoming product acceptance, and design transfer. These issues indicate a systemic lack of robust quality management practices.

## Related Documents

- [483 - 2025-10-24](https://www.globalkeysolutions.net/records/483/iray-imaging-llc/ca3484cc-742c-4fda-9f00-71a7daa15604)

## Related Officers

- [Medical Device Specialist](https://www.globalkeysolutions.net/people/rosanna-m-goodrich/44c5c743-f67b-41fe-9cd1-8b5913bf580e)

Company: https://www.globalkeysolutions.net/companies/iray-imaging-llc/18ab1090-61c5-4ed4-8201-73790d82c223

Office: https://www.globalkeysolutions.net/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22