# FDA 483 - dBMEDx, Inc - March 27, 2025

Source: https://www.globalkeysolutions.net/records/483/dbmedx-inc/b55df468-1e40-4394-858a-d0e728362286

> FDA 483 for dBMEDx, Inc on March 27, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: dBMEDx, Inc
- Inspection Date: 2025-03-27
- Product Type: device
- Office Name: Denver District Office
- Summary: dBMEDx, Inc., a medical device manufacturer in Littleton, CO, was cited for two observations during an FDA inspection. The firm failed to adequately validate a process for testing its BBS Revolution ultrasound devices and did not establish proper procedures for acceptance activities. These issues indicate deficiencies in process control and quality system documentation.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/christine-i-shaw/480cb61e-f173-432d-b84a-c8b492192302)

Company: https://www.globalkeysolutions.net/companies/dbmedx-inc/82780a51-aeff-400d-90ca-40e73b2c7e11

Office: https://www.globalkeysolutions.net/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face