FDA 483 - Mid Central Medical, LLC. - December 09, 2025

An FDA inspection conducted on December 8-9, 2025, at Mid Central Medical, LLC. in St. Vincent, MN, identified three significant deficiencies in its quality system. The firm, a medical device manufacturer, was cited for inadequate procedures for corrective and preventive action (CAPA). Specifically, a design change made to the MCM121 Patient Slider Board following reports of staff injuries was not properly documented, validated, or verified for effectiveness as required by their SOP 107. Additionally, Mid Central Medical, LLC. failed to submit a Medical Device Report (MDR) within 30 days concerning information that suggested a marketed device contributed to a death or serious injury, indicating a critical lapse in adverse event reporting. Finally, the inspection noted that procedures for management review were not adequately established, with no formal review of the quality system's suitability and effectiveness, as it relates to 21 CFR Part 820, conducted since April 2019 per their SOP 106. The company has committed to correcting these observed issues to achieve regulatory compliance.