Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1Failure of your quality unit to exercise its responsibility to ensure the API and intermediates manufactured at your facility are in compliance with CGMP.
Passage 2Failure to ensure that all test procedures are scientifically sound and appropriate to ensure that your intermediate and API conform to established standards of quality and purity.
Passage 3Failure to clean equipment to prevent contamination or carry-over of a material that would alter the quality of the intermediates and API beyond the official or other established specifications.