# FDA 483 - Newman Medical - May 31, 2019

Source: https://www.keypedia.com/records/483/newman-medical/727da757-3243-40cb-af41-53df10696118

> FDA 483 for Newman Medical on May 31, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Newman Medical
- Inspection Date: 2019-05-31
- Product Type: device
- Office Name: Denver District Office
- Summary: An FDA inspection of Newman Medical in Arvada, CO, a medical device manufacturer, revealed significant deficiencies across its quality system. The firm failed to adequately establish procedures for finished device acceptance, complaint handling, corrective and preventive actions, vendor management, and incoming product acceptance. These issues indicate a systemic lack of control over critical manufacturing and quality processes.

## Related Documents

- [483 - 2024-09-25](https://www.keypedia.com/records/483/newman-medical/05fe8288-7b83-421d-b706-43dca87990b2)

## Related Officers

- [Investigator](https://www.keypedia.com/people/vicky-l-cruz/282da571-56be-48f4-96c6-d590829b12c2)

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

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