FDA 483 - Pacific Consolidated Industries LLC - July 25, 2025

An FDA inspection of Pacific Consolidated Industries LLC in Riverside, CA, a medical device manufacturer, revealed significant deficiencies in their quality system. The firm's procedures for corrective and preventive actions (CAPA) were found to be inadequately established and implemented, with issues in classification, timely completion, and record-keeping. Additionally, procedures for design change were insufficient, lacking proper justification, risk assessments, verification, and validation for engineering changes, and inconsistent use of a 510(k) decision flow chart.