FDA 483 - Stericycle Inc - December 21, 2023

An FDA inspection of Stericycle Inc. in Aurora, IL, a manufacturer of Class II containers, revealed significant deficiencies in its quality management system. The firm failed to conduct required management reviews and internal quality audits, both of which were repeat observations from a previous inspection. Additionally, the company did not adequately establish procedures for corrective and preventive actions, failing to document non-conformances and verify the effectiveness of implemented actions.