483
Intego Software LLCFDA 483 - Intego Software LLC - April 24, 2025
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An FDA inspection of Intego Software LLC in Jacksonville, FL, a manufacturer, revealed significant deficiencies in its quality management system. The firm failed to establish procedures for corrective and preventive actions and complaint handling. Additionally, management reviews and quality audits were not performed for multiple years, indicating a fundamental breakdown in quality system oversight.
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ID · d64bfcc3-3a21-4a8e-ad0c-42253870aee4