CRLComplete Response Letter
Complete Response Letter NorthStar Medical Radioisotopes, LLC (Nov 4, 2013)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Safety and adverse events, Chemistry, manufacturing, and controls, Facility inspection and CGMP compliance. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
Issued
US FDA• RADIOGENIX SYSTEM
