FDA 483 - AstraZeneca AB - April 10, 2026

AstraZeneca AB in Sodertalje, Sweden, received a Form 483 with two observations related to inadequate quality control practices. The firm failed to thoroughly investigate unexplained discrepancies, such as foreign particles in tablet batches and recurring equipment performance issues, and its CAPA system was found to be insufficient in preventing the recurrence of deviations.