FDA 483 - Nukemed Inc - May 12, 2022

Nukemed dba Spectron Rx, LLC, a sterile radiologic drug manufacturer in South Bend, IN, was cited for significant deficiencies in its aseptic processing areas. Observations included inadequate environmental monitoring systems, lack of procedures for critical air pattern analysis parameters, and unscientific aseptic personnel practices for inspecting media-filled units. These issues indicate a high risk of microbiological contamination in sterile drug products.