FDA 483 - Northland Nuclear Medicine, LLC - July 13, 2023

Northland Nuclear Medicine, LLC, a PET drug manufacturer in Bismarck, ND, received an FDA Form 483 citing significant deficiencies in its operations. The inspection revealed inadequate production and process controls, including a lack of environmental and personnel monitoring during aseptic manipulations and insufficient equipment cleaning procedures. Additionally, the firm's master production records failed to specify action limits for radiochemical yield.