FDA 483 - LABORATOIRES ANIOS AN ECOLAB COMPANY - September 12, 2024

An FDA inspection of Laboratoires Anios, a drug manufacturer in Sainghin-en-Melantois, France, revealed significant deficiencies in their quality control systems. The firm failed to establish adequate specifications and testing procedures for raw materials and lacked a robust stability testing program for its drug products. These issues raise concerns about the identity, strength, quality, and purity of drugs manufactured and shipped to the U.S.