R.G. Enterprises (U.S.A.) Inc. – FDA 483, Nov 5, 2025

An FDA inspection of R.G. Enterprises (U.S.A.) Inc. in Madison Heights, MI, revealed significant deficiencies in its quality management system for the DataTherm II Continuous Temperature Monitor. The firm failed to establish fundamental procedures across multiple critical areas, including design control, medical device reporting, nonconformance, corrective and preventive actions, quality audits, purchasing control, document control, and management review. These widespread omissions indicate a severe lack of a robust quality system.