483
S. Jackson, IncorporatedFDA 483 - S. Jackson, Incorporated - February 07, 2025
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Record Details
S. Jackson, Incorporated, a medical device manufacturer in Alexandria, VA, was cited for inadequate procedures to control nonconforming product. The firm failed to create nonconformance reports for issues with materials received from its contract manufacturer, including incorrect suture material, needles, and foreign objects. This indicates a significant lapse in quality control processes.
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