FDA 483 - MEDLINE INDUSTRIES, LP - Northfield - January 22, 2024
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This FDA Form 483 report for MEDLINE INDUSTRIES, LP - Northfield details significant deficiencies across multiple quality system areas. The firm failed to adequately establish and follow procedures for Medical Device Reporting, complaint handling, design changes, corrective and preventive actions, and control of purchased products. These issues indicate a systemic breakdown in ensuring device safety, quality, and regulatory compliance, with one observation being a repeat finding.
ID · 645298bf-de08-4ee8-b52e-86f8f60e12ba