# FDA 483 - Ehrin J. Armstrong, MD - January 23, 2020

Source: https://www.keypedia.com/records/483/ehrin-j-armstrong-md/c845326b-b138-44c9-a725-8dd3b6f36d7b

> FDA 483 for Ehrin J. Armstrong, MD on January 23, 2020. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ehrin J. Armstrong, MD
- Inspection Date: 2020-01-23
- Product Type: other
- Office Name: Denver District Office
- Summary: An FDA inspection of Ehrin J. Armstrong, MD, a clinical investigator in Aurora, CO, revealed a significant deviation from an investigational plan. Three subjects were improperly enrolled in a study and received an investigational device despite not meeting the protocol's eligibility criteria. This indicates a failure to conduct the investigation in accordance with the signed agreement and investigational plan.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/ruth-a-williams/f6dd5e30-fe9a-4b18-9703-dc471a55f24f)

Company: https://www.keypedia.com/companies/ehrin-j-armstrong-md/847b6c52-34ed-4074-bb81-72a9991321ec

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