# FDA 483 - MRI CARDIAC SERVICES INCORPORATED - February 24, 2022

Source: https://www.globalkeysolutions.net/records/483/mri-cardiac-services-incorporated/7f1f146b-2325-44ce-baa8-362c06c94e56

> FDA 483 for MRI CARDIAC SERVICES INCORPORATED on February 24, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: MRI CARDIAC SERVICES INCORPORATED
- Inspection Date: 2022-02-24
- Product Type: device
- Office Name: Atlanta District Office
- Summary: MRI Cardiac Services Incorporated, a medical device manufacturer in Winston Salem, NC, was cited for significant deficiencies across its quality system during an FDA inspection. The firm failed to adequately establish procedures for design changes, maintain a complete design history file for its CardioVue System, and properly manage complaint investigations. Additionally, the inspection revealed issues with corrective and preventive action procedures, document control, quality audits, and management review of the quality system.

## Related Officers

- [Christopher B. May](https://www.globalkeysolutions.net/people/christopher-b-may/b2173a59-d37b-41f1-aa39-eefd854722b8)

Company: https://www.globalkeysolutions.net/companies/mri-cardiac-services-incorporated/8011ebf5-b75e-4aba-b0a4-d5f8d4e26819

Office: https://www.globalkeysolutions.net/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7