EnduroMedJune 17, 2025

FDA 483 - EnduroMed - June 17, 2025

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Record Details

EnduroMed, an HCT/P establishment in Brookfield, WI, was inspected by the FDA from June 16-17, 2025. The inspection revealed a significant issue regarding the firm's failure to approve core Current Good Tissue Practice (CGTP) procedures by a responsible person before their implementation. This indicates a fundamental lapse in quality system controls.

Company: EnduroMed
Inspection Date: June 17, 2025
Product Type: Biologics
Office: Minneapolis District Office
Person: Charles D. Boison

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ID · c7b46f03-a50f-4b47-a465-ec2fd334c168