FDA EIR - Advanced Accelerator Applications USA, Inc. - August 18, 2020

An FDA inspection of Advanced Accelerator Applications USA, Inc. (AAA) in Millburn, NJ, was conducted from August 11 to August 18, 2020. This pre-announced audit focused on the company's Current Good Manufacturing Practices (cGMP) for its positron emission tomography (PET) drug manufacturing, specifically Lutathera. It also served as a follow-up to a previous records request. The inspection comprehensively reviewed five key systems: Quality, Facilities and Equipment, Material, Production, and Laboratory Control. A significant aspect of this inspection was the review of corrective actions taken by AAA in response to seven observations issued during a prior cGMP inspection in May 2018. These earlier observations concerned issues such as equipment construction and maintenance, cleaning procedures, production controls, personnel training, laboratory record-keeping, and change control. The FDA determined that AAA had adequately addressed all previous findings. For the current inspection period, auditors found no significant or major deficiencies across any of the reviewed systems. As a result, no FDA Form 483 Inspectional Observations were issued to Advanced Accelerator Applications USA, Inc. during the close-out meeting. A single verbal discussion point was held with management. This outcome indicates the facility's compliance with regulatory standards for PET drug manufacturing, meaning no new formal corrective actions were required from this inspection.