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

An FDA inspection of Advanced Accelerator Applications USA, Inc. (AAA) at its Millburn, NJ facility was conducted from June 18 to June 27, 2024. The inspection provided Current Good Manufacturing Practices (CGMP) and Pre-Approval coverage for New Drug Application (NDA) 215833 Supplement 16, concerning Lutetium LU-177 Vipivotide Tetraxetan Injection, to assess readiness for commercial manufacturing. The inspection resulted in an FDA-483, identifying three main observations. Firstly, AAA accepted reports of analysis from component suppliers for the Lu-177 precursor without adequately establishing the reliability of these analyses through confirmatory testing at appropriate intervals. Secondly, the firm failed to characterize reference standards used for final release testing of its 177Lu-PSMA-617 and Lutathera drug products, impacting data accuracy and reliability. Thirdly, procedures to prevent microbiological contamination were found to be inadequate. This included a lack of a personnel monitoring program for technicians in the Grade C production laboratory and the practice of technicians donning non-sterile coveralls over sterile gowns, undermining aseptic practices. Firm management acknowledged these deficiencies and committed to submitting a written response within 15 business days.