Inland Midwest Corporation – FDA 483, Sep 25, 2025

During an inspection conducted from September 22-25, 2025, Inland Midwest Corporation, a contract manufacturer of medical devices, received an FDA Form 483 outlining two significant observations related to its quality system. The first observation cited inadequate procedures for controlling non-conforming products. The company's written procedure for medical devices, including an accessory for the Prestige LP Cervical Disc, lacked requirements for evaluating nonconformances and determining when investigations are necessary, as demonstrated by an example where an evaluation and justification for not investigating were missing. The second observation noted that a critical manufacturing process, passivation, used for all medical devices, had not been adequately validated. Specifically, during the Installation Qualification of a machine in 2017, test results fell outside required tolerances but were documented and accepted without proper justification, contrary to the firm's Validation Master Plan. These observations indicate deficiencies in the firm's adherence to medical device quality system requirements. Inland Midwest Corporation is required to address these findings by developing and implementing robust corrective and preventive actions to ensure compliance with regulatory standards and the safety and effectiveness of its distributed medical devices.