483
Douglas Medical Products, Inc.FDA 483 - Douglas Medical Products, Inc. - June 24, 2026
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Record Details
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.
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ID · 8954ca52-e084-4976-b7e9-fa20f7ce959a