FDA 483 - Stericycle Inc - February 18, 2025

Stericycle Inc. in Bannockburn, IL, a medical device manufacturer of sharps containers, was cited with six observations during an FDA inspection from February 11-18, 2025. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate procedures for corrective and preventive actions, purchasing controls, complaint handling, design control, servicing activities, and control of nonconforming product. Several observations were repeats from previous inspections, indicating persistent issues with the firm's quality management system.