FDA issued Warning Letter connected to Genetocix Impurities

FDA issued 483 connected to Genotoxic impurities:

  • Failure to establish adequate written procedures for cleaning equipment and its release for use in the manufacture of intermediates and API -Cleaning procedures

  • Failure to establish written procedures to monitor the progress and control the performance of processing steps that may cause variability in the quality characteristics of your intermediates and API -Purging Studies

Link to Warning Letter: