Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1Failure to ensure that all specifications and test procedures are scientifically sound and appropriate to ensure that your API conform to established standards of quality and purity.
Passage 2Failure of your quality unit to exercise its responsibility to ensure the API manufactured at your facility is in compliance with CGMP.
Passage 3Failure to establish adequate written procedures for cleaning equipment and its release for use in manufacture of API.