FDA 483 - Cangene BioPharma, LLC

An FDA inspection of Sanofi Pasteur Biologics, LLC in Rockville, MD, a vaccine manufacturer, revealed three observations. These included deficiencies in a disinfectant efficacy study investigation, an inadequate rationale for not completing product testing, and a lack of extractables/leachables evaluation for a sterilized filling assembly. The findings indicate issues with quality control and process validation.