Lantheus Medical Imaging, Inc. – FDA 483, Apr 9, 2026

Lantheus Medical Imaging, Inc. in North Billerica, MA, was cited for significant deficiencies across its manufacturing and quality control operations. The inspection revealed failures in thoroughly investigating batch failures, particularly concerning high visual inspection defect rates, and inadequate quality control unit procedures, including oversight of contract manufacturers and employee training. Additionally, the firm lacked scientific justification for component sampling, had deficient laboratory controls, and failed to maintain strict control over labeling materials and computer systems.