Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1Failure to establish adequate written procedures for cleaning equipment and its release for use in manufacture of intermediates and API.
Passage 2Failure 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.
Passage 3Failure to investigate all critical deviations.