# FDA 483 - Avalign Integrated Medical Solutions, Inc. - June 28, 2022

Source: https://www.globalkeysolutions.net/records/483/avalign-integrated-medical-solutions-inc/9c1fd538-b7db-411d-aac7-5f67eef7fe5d

> FDA 483 for Avalign Integrated Medical Solutions, Inc. on June 28, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Avalign Integrated Medical Solutions, Inc.
- Inspection Date: 2022-06-28
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: Avalign Integrated, LLC, a medical device manufacturer in Mentor, OH, was inspected by the FDA from June 22-28, 2022. The inspection revealed significant issues with the firm's quality system, specifically regarding the effectiveness of corrective and preventive actions, the handling of product complaints, and the documentation of in-process inspections for Class II bone fixation screws. These findings indicate a need for improved adherence to established procedures and quality control measures.

## Related Officers

- [Brian M Marosan](https://www.globalkeysolutions.net/people/brian-m-marosan/7954e296-d16b-4a87-b773-038732777bb8)

Company: https://www.globalkeysolutions.net/companies/avalign-integrated-medical-solutions-inc/a8d4254c-e0c4-4794-b913-29b9e7ddbb0f

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