Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1Failure to have laboratory control records that include complete data derived from all laboratory tests conducted to ensure your API and intermediates comply with established specifications and standards.
Passage 2Failure of your quality unit to exercise its responsibility to ensure the API and intermediates manufactured at your facility are in compliance with CGMP.
Passage 3Failure to exercise sufficient controls over computerized systems to prevent unauthorized access or changes to data.