483
OnePacs, LLCOnePacs, LLC – FDA 483, Dec 2, 2025
Record Details
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.
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- Chicago District Office
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ID · 7c29b998-4f93-4a15-9e59-157aff56864b
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