# FDA 483 - Newman Medical - September 25, 2024

Source: https://www.globalkeysolutions.net/records/483/newman-medical/05fe8288-7b83-421d-b706-43dca87990b2

> FDA 483 for Newman Medical on September 25, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Newman Medical
- Inspection Date: 2024-09-25
- Product Type: device
- Office Name: Denver District Office
- Summary: An FDA inspection of Newman Medical, a medical device manufacturer in Arvada, CO, revealed significant deficiencies across its quality system. The firm failed to adequately establish procedures for corrective and preventive actions (a repeat observation), servicing activities, design changes, and acceptance activities. Additionally, the inspection found issues with maintaining device history records and a complete lack of device master records for its Class 2 finished devices.

## Related Documents

- [483 - 2019-05-31](https://www.globalkeysolutions.net/records/483/newman-medical/727da757-3243-40cb-af41-53df10696118)

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/newman-medical/9ccbc85f-9be9-443e-850f-c5d99d5eefa6

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