FDA 483 - Advanced Accelerator Applications USA, Inc. - November 09, 2021

Advanced Accelerator Applications USA, Inc. in Millburn, NJ, a sterile drug product manufacturer, was cited for significant deficiencies in its quality control, investigation, and reporting systems. The inspection revealed failures to notify customers about out-of-specification or compromised batches of LUTATHERA, inadequate investigations into production discrepancies, and a lack of timely field alert reports. Additional concerns included deteriorating equipment surfaces, incomplete master batch records, poor equipment cleaning logs, and insufficient raw material supplier qualification and testing.