FDA 483 - Advanced Accelerator Applications USA, Inc. - June 27, 2024

Advanced Accelerator Applications USA, Inc. in Millburn, NJ, a drug manufacturer, was cited for significant deficiencies during an FDA inspection. The observations include failures in qualifying component suppliers, incomplete laboratory records for reference standards, and critical lapses in procedures to prevent microbiological contamination of sterile drug products. These issues indicate a lack of adequate controls over critical manufacturing processes and quality assurance.