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

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.