# FDA 483 - RevZero Inc - April 18, 2025

Source: https://www.keypedia.com/records/483/revzero-inc/fb5e9e81-7f95-4937-9bbb-286e72c15210

> FDA 483 for RevZero Inc on April 18, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: RevZero Inc
- Inspection Date: 2025-04-18
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of RevZero, Inc. in Chanhassen, MN, a device manufacturer, identified two significant observations. The firm's procedures for corrective and preventive actions were found to be inadequately established, resulting in failures to consistently identify actions, verify effectiveness, and maintain proper documentation. Additionally, the company lacked sufficient procedures for controlling nonconforming product, specifically regarding the evaluation for investigations and disposition by authorized personnel.

## Related Officers

- [investigator](https://www.keypedia.com/people/tyler-r-courtney/08ea96c4-cd5a-4793-b7e4-fb2b9ee2b9ef)

Company: https://www.keypedia.com/companies/revzero-inc/f918dce1-73a9-4f36-b7cf-a25316a44b0b

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d