IntelGenx Corp. – FDA 483, Feb 25, 2022

Intelgenx Corp. in Saint-Laurent, a drug manufacturer, was cited for significant deficiencies during an FDA inspection. The firm failed to use stability testing results to support product expiration dates, with multiple batches showing out-of-specification impurity levels due to degradation. Additionally, the company did not formally validate an Excel-based spreadsheet used for critical drug product release calculations, impacting the accuracy and reliability of assay and impurity determinations.