FDA 483 - Oak Ridge Products - April 01, 2026

Oak Ridge Products, LLC, a manufacturer of Class II Slide Lid Sharp Containers in McHenry, IL, was cited for six observations during an FDA inspection. The inspection revealed significant deficiencies in their quality management system, particularly concerning documentation for design changes, corrective actions, nonconforming products, complaint handling, management reviews, and internal audits. These issues indicate a systemic lack of adherence to established procedures and regulatory requirements.