Injunction n ° 2024_MEDCHIM_121_INJ-C3 of 03/06/2025 relating to the establishment of the company Guerbet Produtos Radiologicos located in Rio de Janeiro (Brasil) Rua André Rocha 3000 Jacarepagua

The inspection report highlights significant non-conformities and shortcomings at Guerbet Produtos Radiologicos' facility in Rio de Janeiro, Brazil. The deficiencies pertain to deteriorated facilities, inadequate quality control measures, and insufficient process management. Key compliance considerations for the company include: - Remediating facilities, equipment, and utilities within 12 months. - Implementing a visual inspection process with qualified personnel within 4 months. - Developing a strategy to manage critical process parameters within 6 months.