FDA 483 - Vistin Pharma AS avd Kragero Fikkjebakke - January 31, 2025

An FDA inspection of Vistin Pharma, an API manufacturer in Samidal, Norway, revealed significant deficiencies in their quality system. Observations included inadequate deviation investigations and corrective actions, insufficient testing of recycled solvents used in drug substance production, and a lack of written procedures for reporting product quality defects, specifically Field Alert Reports, to health authorities within specified timelines.