Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1Failure to test the identity of each lot of incoming production material.
Passage 2Failure of your quality unit to establish a system to release or reject raw materials, intermediates, packaging, and labeling materials.
Passage 3Failure to address deviations may also cause FDA to withhold issuance of Export Certificates. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any deviations are completely addressed and we confirm your compliance with CGMP. We may inspect your facility to verify that you have completed corrective actions to address any deviations.