Northland Nuclear Medicine, LLC – FDA 483, May 29, 2026
Northland Nuclear Medicine, LLC, a PET Drug Manufacturer in Bismarck, ND, was cited for significant deficiencies during an FDA inspection. The observations included inadequate facilities for preventing contamination, specifically concerning environmental monitoring, aseptic technique, and smoke studies. Additionally, the firm's corrective and preventive action (CAPA) system lacked proper effectiveness checks, and written procedures for ensuring component suitability were found to be inadequate.
ID · 0ee840fc-c882-43b7-9467-3d023f2ae474
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