# FDA 483 - Rocky Mountain Research, Inc. - July 16, 2019

Source: https://www.keypedia.com/records/483/rocky-mountain-research-inc/d8a2f56b-0533-4c70-af15-e2fa07b00a1e

> FDA 483 for Rocky Mountain Research, Inc. on July 16, 2019. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Rocky Mountain Research, Inc.
- Inspection Date: 2019-07-16
- Product Type: device
- Office Name: Denver District Office
- Summary: Rocky Mountain Research, Inc., a medical device manufacturer in Park City, UT, received a Form FDA-483 with three observations. The inspection revealed deficiencies in documenting the effectiveness of corrective actions, establishing adequate procedures for verifying servicing requirements, and ensuring independence in quality audits. These issues indicate a need for improved quality system controls at the facility.

## Related Officers

- [James R. Montero](https://www.keypedia.com/people/james-r-montero/ce2d19fd-25b7-423e-9132-5d6f582380d2)

Company: https://www.keypedia.com/companies/rocky-mountain-research-inc/a6c251b2-04f0-4f6a-8766-69d1f341d48f

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