FDA 483 - OnePacs, LLC - December 02, 2025

An FDA inspection of OnePacs, LLC in Machesney Park, IL, a manufacturer of OnePACS software, revealed significant deficiencies in their quality system. The firm failed to adequately establish and follow procedures for design validation, corrective and preventive actions, management review, and quality audits. These issues indicate a systemic lack of proper documentation and adherence to established quality processes.