FDA 483 - MedTorque Inc. - September 25, 2025
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An FDA inspection of Inland Midwest Corporation, a contract manufacturer of medical devices in Elmhurst, IL, revealed significant deficiencies in their quality system. The firm was cited for inadequate procedures for controlling non-conforming products, specifically lacking requirements for evaluating nonconformances and determining when investigations are necessary. Additionally, a critical manufacturing process (passivation) was not adequately validated, with out-of-tolerance results accepted without proper justification.
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ID · 81c27e78-2d52-4746-b72d-59aa3f10b957