FDA 483 - AbbVie Inc. - June 18, 2024

AbbVie Inc. in North Chicago, IL, a sterile drug manufacturer, was cited for deficiencies in laboratory controls. The inspection revealed that the firm lacked scientifically sound justification for its Survanta stability testing program and failed to protect microbiology plates from desiccation during incubation. These issues indicate a failure to ensure the quality and purity of drug products and in-process materials.