FDA 483 - Stericycle Inc - February 27, 2020

Stericycle Inc. in Northbrook, IL, a specifications developer/refurbisher, was cited with six observations during an FDA inspection from February 24-27, 2020. The inspection revealed significant deficiencies in their quality system, particularly concerning corrective and preventive actions, record-keeping, organizational structure, quality policy establishment, quality audits, and software validation. Several issues, including CAPA procedures, were noted as repeat observations from a previous 2012 FDA inspection, indicating persistent non-compliance.