FDA 483 - Bracco Imaging Spa C/O Bioindustry - April 12, 2022

An FDA inspection of Bracco Imaging Spa C/O Bioindustry identified significant deficiencies in their drug manufacturing operations. The firm failed to adhere to qualified production processes for aseptic filling, leading to deviations in filling duration, product hold time, and filter usage. Additionally, the inspection revealed inadequate environmental monitoring in aseptic processing areas and a lack of proper training for personnel responsible for aseptic setup and microbial sampling.