# FDA 483 - Aurora Healthcare US Corp - February 17, 2022

Source: https://www.globalkeysolutions.net/records/483/aurora-healthcare-us-corp/a4fe15f3-63e5-45ed-87c8-852db1ccdd35

> FDA 483 for Aurora Healthcare US Corp on February 17, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Aurora Healthcare US Corp
- Inspection Date: 2022-02-17
- Product Type: device
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: An FDA inspection of Aurora Healthcare US Corp in Danvers, MA, a manufacturer of the Aurora Dedicated Breast MRI System, revealed multiple significant procedural deficiencies. Observations included inadequate procedures for supplier quality management, corrective and preventive actions, complaint handling, management review, and quality audits. One observation regarding supplier re-evaluation was a repeat finding, indicating a persistent lack of compliance.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/james-p-finn/70e5c36c-2711-449b-bf73-e08b4dd58449)

Company: https://www.globalkeysolutions.net/companies/aurora-healthcare-us-corp/dbc94faa-cf2e-4b90-9713-1a2abf366b16

Office: https://www.globalkeysolutions.net/offices/fda-district-office-stoneham-massachusetts/1daceb4f-4057-46cf-af02-d4ccde44dcc7