# FDA 483 - KORR Medical Technologies, Inc. - March 17, 2022

Source: https://www.keypedia.com/records/483/korr-medical-technologies-inc/c7ad9468-9369-4442-bada-e409134b60f0

> FDA 483 for KORR Medical Technologies, Inc. on March 17, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: KORR Medical Technologies, Inc.
- Inspection Date: 2022-03-17
- Product Type: device
- Office Name: Denver District Office
- Summary: KORR Medical Technologies, Inc. in Salt Lake City, UT, a medical device manufacturer, was cited for significant deficiencies in its quality system during an FDA inspection. Observations included inadequate documentation of corrective and preventive actions, poorly maintained device history and master records, untimely closure of complaint files, and a failure to conduct internal quality audits for an extended period. These issues indicate a systemic breakdown in maintaining quality system compliance.

## Related Officers

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

Company: https://www.keypedia.com/companies/korr-medical-technologies-inc/0ff5c8a9-9b3e-4bcc-b8b8-97e4e6b2e80d

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