# FDA 483 - ARUP Laboratories, Inc. - December 17, 2025

Source: https://www.keypedia.com/records/483/arup-laboratories-inc/4b17dabf-87ee-4669-9e2f-d365aa82596e

> FDA 483 for ARUP Laboratories, Inc. on December 17, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ARUP Laboratories, Inc.
- Inspection Date: 2025-12-17
- Product Type: device
- Office Name: Denver District Office
- Summary: ARUP Laboratories, Inc. in Salt Lake City, UT, a medical device manufacturer, received a Form FDA 483 with four observations. The inspection revealed significant deficiencies in the firm's quality system, specifically regarding corrective and preventive actions, design control, device history records, and quality audits. These issues indicate a lack of adequate procedures and documentation across critical manufacturing and quality processes.

## Related Documents

- [EIR - 2019-03-11](https://www.keypedia.com/records/eir/arup-laboratories-inc/bb520b13-9a57-4a7b-b446-380d04cb3101)

## Related Officers

- [investigator](https://www.keypedia.com/people/matthew-m-vernon/f77e8c18-8614-49e3-9b19-3327b7fe7648)

Company: https://www.keypedia.com/companies/arup-laboratories-inc/5aba7097-90ba-4744-a156-5354d35b65f7

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