Douglas Medical Products, Inc. – FDA 483, Jun 24, 2026

Douglas Medical Products, Inc. in Mundelein, IL, a specification developer for Class II medical devices, was cited for multiple quality system deficiencies during an FDA inspection. The firm failed to adequately apply a risk-based approach, implement effective corrective actions for particulate matter complaints, and properly control design changes. Additionally, the inspection revealed a failure to maintain adequate records for vendor evaluations.