Northland Nuclear Medicine, LLC – FDA Warning Letter, May 29, 2026

The FDA issued a warning letter to Northland Nuclear Medicine, LLC, following an inspection conducted from May 26 to 29, 2026, at its Bismarck, North Dakota facility. The inspection identified significant violations of Current Good Manufacturing Practice (CGMP) regulations for positron emission tomography (PET) drugs, specifically under 21 CFR Part 212. The FDA noted that the firm’s drug products are considered substandard due to these manufacturing failures.

Key issues included a systematic failure to investigate environmental monitoring failures and manufacturing deficiencies. The company documented over 100 microbial recoveries in high-grade sterile areas but failed to identify the organisms or implement effective corrective actions. Additionally, the firm repeatedly failed to meet drug yield specifications; rather than identifying the root cause, management simply lowered the yield limits. Other violations involved using compromised testing materials exposed to disinfectants, inadequate airflow visualization studies, and insufficient equipment disinfection procedures.

Because these are repeat violations previously discussed with the firm in 2023, the FDA expressed concern over the adequacy of management"s oversight. Northland Nuclear Medicine is required to engage an independent consultant to audit its entire operation. The firm must provide a comprehensive risk assessment of its sterile processes, implement a remediated environmental monitoring program, and conduct new dynamic airflow studies. A formal response addressing these deficiencies and providing a plan for retrospective batch evaluations must be submitted within 15 business days.