FDA EIR - Advanced Accelerator Applications USA, Inc. - August 25, 2023

An FDA inspection of Advanced Accelerator Applications USA, Inc. in Millburn, NJ, occurred from August 21-25, 2023. The primary objective was pre-approval coverage for NDA-215833-SUPPL-8, Lutetium (177LU) Vipivotide Tetraxetan for injection/infusion, conducted under Compliance Programs for Sterile Drug Process and Preapproval Inspections. Significantly, this inspection concluded with no FDA Form 483 observations issued, and an initial approval recommendation was communicated. This outcome contrasts with a previous inspection (October-November 2022) where a Form 483, classified as Voluntary Action Indicated, cited deficiencies including inadequate written procedures for production and quality control, equipment calibration issues, lack of microbiological contamination prevention procedures for sterile drugs, and insufficient discrepancy reviews. During the current review of Laboratory Systems, a transcription error was noted in stability data submitted for the new drug, though all results were within specification and no significant deficiencies were observed. A field alert was also identified concerning the mis-shipment of expired Pluvicto vials within containers for a current batch; however, no patient doses were administered, and a root cause investigation is underway. Overall, the company demonstrated readiness for the commercial manufacturing of the new radiopharmaceutical product.