Advanced Accelerator Applications USA, Inc. – FDA 483, Nov 3, 2022

The FDA inspected Advanced Accelerator Applications USA, Inc. in Millburn, NJ, a sterile drug manufacturer, and issued a Form 483. The inspection revealed significant deficiencies in production and process controls, including incomplete equipment qualifications and overdue calibrations. Additionally, the quality control unit failed to adequately manage investigations and alarm reviews, and procedures to prevent microbiological contamination were not established, indicating a lack of robust quality systems.