FDA 483 - Northland Nuclear Medicine, LLC - June 07, 2019

An FDA inspection of Northland Nuclear Medicine, LLC in Bismarck, ND, a manufacturer of PET drugs, revealed significant deficiencies. The firm lacked adequate production and process controls, including issues with aseptic process simulations, data integrity, and vendor qualification. Additionally, critical equipment was not properly qualified, and master production records were incomplete, raising concerns about the consistent quality and purity of their 18F-FDG product.