Shine Spect USA, LLC – FDA 483, Jul 10, 2026

An FDA inspection of Shine Spect Usa, LLC in North Billerica, MA, a radiopharmaceutical manufacturer, revealed two significant observations. The firm failed to provide adequate environmental controls, including proper HVAC design, air pressure differentials, and environmental monitoring, leading to contamination risks during drug product assembly. Additionally, critical drug product contact equipment was not cleaned and sanitized at appropriate intervals, further increasing contamination potential.