South Dakota Partners Inc – FDA 483, Sep 30, 2024

South Dakota Partners Inc. in Clear Lake, SD, was inspected by the FDA from September 23-30, 2024, and received a Form FDA-483 with five observations. The inspection revealed significant deficiencies in quality system procedures, including inadequate supplier evaluation, control of nonconforming product, finished device acceptance, calibration, and process validation. These issues indicate a need for comprehensive improvements across multiple manufacturing and quality control processes.