FDA 483 - South Dakota Partners Inc - September 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.