FDA EIR - Advanced Accelerator Applications USA, Inc. - November 03, 2022

An FDA inspection of Advanced Accelerator Applications USA, Inc.'s manufacturing facility in Millburn, NJ, occurred from October 24 to November 3, 2022. This inspection was a follow-up to a previous assessment and focused on evaluating the company's adherence to Current Good Manufacturing Practices (CGMP) for its sterile radiopharmaceutical products, including commercial Lutathera and clinical batches of Pluvicto. At the inspection's conclusion, an FDA Form 483 was issued, outlining five key observations. These included a lack of adequate written procedures for production and process controls to ensure drug product quality and consistency. Additionally, responsibilities and procedures for the quality control unit were not fully documented or followed, and routine equipment calibration, inspection, and checking were not conducted according to a written program. The facility also lacked established procedures to prevent microbiological contamination in its sterile drug products, and there was a failure to thoroughly investigate all unexplained discrepancies, even for distributed batches. The company's Site Head, Mr. Sergio Cerdas Castro, committed to submitting a written response to the FDA within 15 business days addressing these findings.