483
Bracco Imaging Spa C/O BioindustryBracco Imaging Spa C/O Bioindustry – FDA 483, Apr 12, 2022
Record Details
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.
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ID · aefe2e89-89e6-40f1-bf45-c4951b8eb4b9
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