# FDA 483 - ERI Group - September 20, 2019

Source: https://www.keypedia.com/records/483/eri-group/1d88d7b9-15c0-459a-8e08-611a1ffac755

> FDA 483 for ERI Group on September 20, 2019. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: ERI Group
- Inspection Date: 2019-09-20
- Product Type: device
- Office Name: Denver District Office
- Summary: Evergreen Research, Inc. in Golden, CO, was inspected and cited for significant deficiencies in its quality system. The inspection revealed inadequate procedures for environmental controls in cleanrooms, finished device acceptance, and incoming product acceptance. These issues indicate a moderate level of severity, impacting product quality and regulatory compliance.

## Related Officers

- [Investigator](https://www.keypedia.com/people/vicky-l-cruz/282da571-56be-48f4-96c6-d590829b12c2)
- [Creighton T. Tuzon](https://www.keypedia.com/people/creighton-t-tuzon/be0d09c0-59f4-48c3-9e3d-a1ceb2587e3e)

Company: https://www.keypedia.com/companies/eri-group/3d52d397-5b04-40a3-9fb3-b5c404175af1

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