FDA 483 - PROVISIO MEDICAL INC - February 27, 2026

PROVISIO MEDICAL INC, a medical device manufacturer in San Diego, CA, was cited for significant deficiencies during an FDA inspection. Observations included failures to adequately address nonconforming catheters, implement proper design change controls, and ensure effective corrective actions to prevent recurrence of issues. These findings suggest a breakdown in the firm's quality management system.