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

An FDA cGMP and Pre-Approval inspection of Advanced Accelerator Applications USA, Inc. (AAA) in Millburn, NJ, was conducted from October 20 to November 09, 2021. The inspection evaluated sterile drug manufacturing operations and the pre-approval of Lutetium (177LU) vipivotide tetraxetan injection, covering key areas like Quality, Facilities, and Production under applicable regulatory frameworks.

The inspection identified several critical deficiencies, documented in a 7-item FDA-483. Main violations included inadequate written procedures and non-adherence by the quality control unit, a failure to thoroughly investigate unexplained discrepancies and out-of-specification results for distributed products, and the absence of timely NDA-Field Alert Reports for distributed batches with quality issues or manufacturing breaches. Further observations highlighted reactive or absorptive equipment surfaces impacting drug quality, a lack of theoretical yield statements in master production records, and insufficient documentation of equipment cleaning and usage. Additionally, the company accepted component supplier analyses without adequate in-house identity testing or validation.

Advanced Accelerator Applications' management acknowledged the observations and committed to implementing corrective actions. They also pledged to submit a comprehensive written response to the agency within 15 business days to address all identified issues.