FDA 483 - InfoRLife SA - May 03, 2024

InforLife SA, a sterile drug manufacturer in Campascio, Switzerland, received a Form 483 with two observations. The firm's quality control unit failed to approve or reject procedures, leading to the release of drug products with high impurity levels from packaging material. Additionally, the firm lacked adequate written procedures for production and process controls, resulting in visual inspection issues with air bubbles and cloudiness in drug products.