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

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.