FDA 483 - Advanced Accelerator Applications (Italy) srl - September 03, 2019

This FDA Form 483 was issued to Advanced Accelerator Applications in Colleretto Giacosa, Italy, following an inspection of their PET and sterile drug product manufacturing facility. The inspection revealed significant deficiencies in aseptic processing, environmental monitoring, container handling, adherence to visual inspection procedures, and laboratory controls. These issues indicate a moderate to severe risk of product contamination and quality control failures.