483
Best Vascular, IncFDA 483 - Best Vascular, Inc - July 11, 2025
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An FDA inspection of Best Vascular, Inc. in Norcross, GA, from July 5-11, 2025, revealed a significant quality system deficiency. The firm failed to adequately document corrective and preventive action (CAPA) activities and effectiveness checks, as required by its own procedures. This indicates a breakdown in the company's quality management processes for its Class III medical device manufacturing.
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ID · 119bbe39-1813-4c6d-b534-e6bb3319dc5b