Freeland Systems, Llc – FDA 483, Jul 17, 2026

An FDA inspection of Freeland Systems, Llc in Carmel, IN, a manufacturer of a software medical device, revealed significant deficiencies across its quality management system. The firm failed to adequately document and implement procedures for design control, quality data analysis, internal audits, management review, purchasing controls, and record management. These observations indicate a systemic lack of a robust quality system, posing a moderate to severe risk to product quality and regulatory compliance.